510(k) Report

510(k) · Cleared

Cleared

Alpha Bio Dental Implant System

K063364510(k) TraditionalCleared Mar 14, 2007127-day reviewClass II21 CFR 872.3640

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Alpha-Bio Tec, Ltd. · DZE Implant, Endosseous, Root-Form

Cleared on Mar 14, 2007 as substantially equivalent to K022009 (Implant Innovations, Inc., 2002) and 13 other predicates after a 127-day review. Its family tree reaches back 9 generations to 1996. 187 later devices descend from it.

Decided
Mar 14, 2007
Review
127 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
14

Its longest line of descent runs back 9 generations to K960026 (1996). 75 ancestors in all, the oldest K874590 (1988). 187 later devices descend from it, 13 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 3 other ancestors2003: 7 other ancestors2002: 8 other ancestors2001: 10 other ancestors2000: 6 other ancestors1999: 7 other ancestors1998: 3 other ancestors1997: 3 other ancestors1996: 7 other ancestors1995: 3 other ancestors1990: 3 other ancestors1988: 1 other ancestor1994: 2 other ancestors1993: 2 other ancestors1989: 1 other ancestor2008: 2 descendants cleared2012: 5 descendants cleared2014: 9 descendants cleared2017: 5 descendants cleared2015: 7 descendants cleared2011: 1 descendant cleared2010: 1 descendant cleared2021: 14 descendants cleared2013: 5 descendants cleared2019: 13 descendants cleared2020: 16 descendants cleared2016: 5 descendants cleared2024: 20 descendants cleared2018: 8 descendants cleared2022: 20 descendants cleared2025: 24 descendants cleared2023: 18 descendants cleared2026: 14 descendants clearedK960026 · Biohorizons Dental Implant System · BioHorizons Implant Systems, Inc. · 1996K964330 · Biohorizons Dental Implant System (Name Subject to Change) · BioHorizons Implant Systems, Inc. · 1997K972313 · The Maestro System · BioHorizons Implant Systems, Inc. · 1997×2: 2 generations cleared close together, K020133 (2002), K020645 (2002) K022795 · Modification to the Maestro System · BioHorizons Implant Systems, Inc. · 2002K030463 · Modification to the Maestro System · BioHorizons Implant Systems, Inc. · 2003 · recalledK032351 · The Maestro System 3.0MM Diameter Implant · BioHorizons Implant Systems, Inc. · 2003K041938 · Maximus OS (Overdenture System) · BioHorizons Implant Systems, Inc. · 2004 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 12 other ancestors2 generations back: 32 other ancestors3 generations back: 20 other ancestors4 generations back: 1 other ancestor5 generations back: 1 other ancestor 1 generation forward: 13 descendants2 generations forward: 25 descendants3 generations forward: 35 descendants4 generations forward: 24 descendants5 generations forward: 26 descendants6 generations forward: 25 descendants7 generations forward: 17 descendants8 generations forward: 7 descendants9 generations forward: 7 descendants10 generations forward: 6 descendants11 generations forward: 1 descendant12 generations forward: 1 descendant K041938 · Maximus OS (Overdenture System) · BioHorizons Implant Systems, Inc. · 2004 · recalledK032351 · The Maestro System 3.0MM Diameter Implant · BioHorizons Implant Systems, Inc. · 2003K030463 · Modification to the Maestro System · BioHorizons Implant Systems, Inc. · 2003 · recalledK022795 · Modification to the Maestro System · BioHorizons Implant Systems, Inc. · 2002K020645 · Modification to the Maestro System · BioHorizons Implant Systems, Inc. · 2002K020133 · Modification to the Maestro System · BioHorizons Implant Systems, Inc. · 2002K972313 · The Maestro System · BioHorizons Implant Systems, Inc. · 1997K964330 · Biohorizons Dental Implant System (Name Subject to Change) · BioHorizons Implant Systems, Inc. · 1997K960026 · Biohorizons Dental Implant System · BioHorizons Implant Systems, Inc. · 1996−50+5+10
  1. Root · 9 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
  2. 5 generations between
  3. 3 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
  4. 2 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
  5. 1 generation backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
  6. This deviceK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
  7. Descendant · cites it directly · 141 of its ownK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
  8. Descendant · 2 generations on · 127 of its ownK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
  9. Descendant · 3 generations on · 123 of its ownK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
  10. Descendant · 3 generations on · 109 of its ownK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
  11. Descendant · 3 generations on · 89 of its ownK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
Show all 9 generations
  1. Root · 9 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
  2. 8 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
  3. 7 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
  4. 6 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
  5. 5 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
  6. 4 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
  7. 3 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
  8. 2 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
  9. 1 generation backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
  10. This deviceK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007

Showing 5 of 187 descendants. See all descendants

Descendants cleared per year

2008: 22010: 12011: 12012: 52013: 52014: 92015: 72016: 52017: 52018: 82019: 132020: 162021: 142022: 202023: 182024: 202025: 242026: 14
2008high 24 (2025) · low 0 (2009)2026

Most influential descendants

Showing 5 of 187 · See all
  • K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · cites it directly141descendants
  • K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013 · 2 generations on127descendants
  • K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014 · 3 generations on123descendants
  • K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc. · 2014 · 3 generations on109descendants
  • K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015 · 3 generations on89descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K960026Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc.1996—
−8K964330Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc.1997—
−7K972313The Maestro SystemBioHorizons Implant Systems, Inc.1997—
−6K020133Modification to the Maestro SystemBioHorizons Implant Systems, Inc.2002—
−5K020645Modification to the Maestro SystemBioHorizons Implant Systems, Inc.2002—
−4K022795Modification to the Maestro SystemBioHorizons Implant Systems, Inc.2002—
−3K030463Modification to the Maestro SystemBioHorizons Implant Systems, Inc.20031
−2K032351The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc.2003—
−1K041938Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc.20042
0 (this device)K063364Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd.2007—
+1K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp.20081
+2K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013—
+3K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014—
+3K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart…Neodent USA, Inc.2014—
+3K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
198910
199030
199320
199420
199530
199670
199730
199830
199970
200060
2001100
200280
200370
200430

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200820
201010
201110
201250
201350
201490
201570
201650
201750
201880
2019130
2020160
2021140
2022200
2023180
2024200
2025240
2026140
FIG. 1 — Lineage of K063364, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DZE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DZE device

  1. #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (14)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K0220093I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants
Summary page 2
…Traditional FDA 510k Page 106 of 109 F. Predicate Devices: The Alpha-Bio Tee® is substantially equivalent to 3i® K022009;K022113; Zimmer Tapered screw vent K013227; MIS Implant Technologies Ltd K040807, K003191 ; Biohorizons…
Implant Innovations, Inc.2002—
*K0221133I Dental Implant Accessories
Summary page 2
…nal FDA 510k Page 106 of 109 F. Predicate Devices: The Alpha-Bio Tee® is substantially equivalent to 3i® K022009;K022113; Zimmer Tapered screw vent K013227; MIS Implant Technologies Ltd K040807, K003191 ; Biohorizons…
Implant Innovations, Inc.2002—
*K013227Screw Vent Implant; Tapered Screw Vent Implant
Summary page 2
…age 106 of 109 F. Predicate Devices: The Alpha-Bio Tee® is substantially equivalent to 3i® K022009;K022113; Zimmer Tapered screw vent K013227; MIS Implant Technologies Ltd K040807, K003191 ; Biohorizons K041938; K032351; NobelD…
Sulzer Dental, Inc.20012
*K040807Mis Dental Implant System
Summary page 2
…is substantially equivalent to 3i® K022009;K022113; Zimmer Tapered screw vent K013227; MIS Implant Technologies Ltd K040807, K003191 ; Biohorizons K041938; K032351; NobelDirectTM K041876; IMTEC K031106 K023067…
Mis - Implant Technologies, Ltd.2004—
*K003191Mis Implant System Decive
Summary page 2
…substantially equivalent to 3i® K022009;K022113; Zimmer Tapered screw vent K013227; MIS Implant Technologies Ltd K040807, K003191 ; Biohorizons K041938; K032351; NobelDirectTM K041876; IMTEC K031106 K023067; Branema…
Mis Implants Technologies, Ltd.2001—
*K041938Maximus OS (Overdenture System)
Summary page 2
…K022009;K022113; Zimmer Tapered screw vent K013227; MIS Implant Technologies Ltd K040807, K003191 ; Biohorizons K041938; K032351; NobelDirectTM K041876; IMTEC K031106 K023067; Branemark K022562, Straumann K033984; K013798;…
BioHorizons Implant Systems, Inc.20042
*K032351The Maestro System 3.0MM Diameter Implant
Summary page 2
…K022009;K022113; Zimmer Tapered screw vent K013227; MIS Implant Technologies Ltd K040807, K003191 ; Biohorizons K041938; K032351; NobelDirectTM K041876; IMTEC K031106 K023067; Branemark K022562, Straumann K033984; K013798;…
BioHorizons Implant Systems, Inc.2003—
*K041876Nobeldirect OD Implant
Summary page 2
…immer Tapered screw vent K013227; MIS Implant Technologies Ltd K040807, K003191 ; Biohorizons K041938; K032351; NobelDirectTM K041876; IMTEC K031106 K023067; Branemark K022562, Straumann K033984; K013798; SWISSPLUS IMPL…
Nobel Biocare Uas, Inc.2004—
*K031106Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XX
Summary page 2
…crew vent K013227; MIS Implant Technologies Ltd K040807, K003191 ; Biohorizons K041938; K032351; NobelDirectTM K041876; IMTEC K031106 K023067; Branemark K022562, Straumann K033984; K013798; SWISSPLUS IMPLANT CORE VENT C…
Imtec Corp.20031
*K023067Imtec Sendax Mdi ORTHO6 and ORTHO8
Summary page 2
…Implant Technologies Ltd K040807, K003191 ; Biohorizons K041938; K032351; NobelDirectTM K041876; IMTEC K031106 K023067; Branemark K022562, Straumann K033984; K013798; SWISSPLUS IMPLANT CORE VENT CORP K002188 in terms of intend…
Imtec Corp.2002—
*K022562Various Branemark System Implants-Immediate Function Indication
Summary page 2
…ant Technologies Ltd K040807, K003191 ; Biohorizons K041938; K032351; NobelDirectTM K041876; IMTEC K031106 K023067; Branemark K022562, Straumann K033984; K013798; SWISSPLUS IMPLANT CORE VENT CORP K002188 in terms of intended…
Nobel Biocare AB2002—
*K033984Straumann Dental Implant System
Summary page 2
…d K040807, K003191 ; Biohorizons K041938; K032351; NobelDirectTM K041876; IMTEC K031106 K023067; Branemark K022562, Straumann K033984; K013798; SWISSPLUS IMPLANT CORE VENT CORP K002188 in terms of intended use, indicati…
Institut Straumann AG2004—
*K013798Prosthetic Accessories to the Iti Dental Implant System
Summary page 2
…, K003191 ; Biohorizons K041938; K032351; NobelDirectTM K041876; IMTEC K031106 K023067; Branemark K022562, Straumann K033984; K013798; SWISSPLUS IMPLANT CORE VENT CORP K002188 in terms of intended use, indications for u…
Institut Straumann AG2001—
*K002188Swissplus Implant System, Model SPWB 8,10,12,14/OPH20/SMPR, SPB…
Summary page 2
…NobelDirectTM K041876; IMTEC K031106 K023067; Branemark K022562, Straumann K033984; K013798; SWISSPLUS IMPLANT CORE VENT CORP K002188 in terms of intended use, indications for use, technological characteristics, perform…
Core-Vent Corp.2000—

Also cleared against K022009: 12 other devices →

What descends from it? (187)

See all 187

13 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp.2008141
K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236
K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425
K071803Ards Dental ImplantsArds, Ltd.200813
K112795Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.201211
K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146
K162299Spiral Shape Dental Implant SystemGp Implants20173
K133362SGS Dental ImplantSgs International, Ltd.20142
K202092ABC Dental Implant SystemAbracadabra Implants, Ltd.20210
K150363NOVA Dental Implants SystemNova Implants, Ltd.20150

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 8 months on median.
  • 7 of the 75 ancestors have a recall of any class.
  • Of its descendants, K081653 (Imtec Corp., 2008) has gone furthest, with 141 descendants of its own.
  • 12 other devices also cite its predicate K022009.

How does its category compare?

All DZE devices

DZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · DZE

31in 2025

2007: 432008: 612009: 412010: 342011: 262012: 392013: 422014: 362015: 362016: 402017: 482018: 412019: 312020: 412021: 342022: 342023: 352024: 402025: 312026 (partial year): 15
2007high 61 (2008) · low 26 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DZE

184in 2025

2007: 107 days median2008: 118 days median2009: 110 days median2010: 162 days median2011: 194 days median2012: 174 days median2013: 195 days median2014: 265 days median2015: 215 days median2016: 219 days median2017: 223 days median2018: 200 days median2019: 231 days median2020: 230 days median2021: 182 days median2022: 243 days median2023: 248 days median2024: 222 days median2025: 184 days median2026 (partial year): 194 days median
2007high 265 (2014) · low 107 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DZE

1in 2025

2007: 112008: 42009: 32010: 32012: 112013: 12014: 72015: 32016: 152017: 42018: 42019: 82021: 62024: 12025: 12026 (partial year): 2
2007high 15 (2016) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DZE

465,788in 2025

2007: 2252008: 3932009: 1642010: 3602011: 3622012: 3582013: 3912014: 1,1242015: 2,8942016: 1,1162017: 9,7192018: 12,8922019: 167,0162020: 255,5242021: 479,6182022: 483,2242023: 537,5852024: 473,6292025: 465,788
2007high 537,585 (2023) · low 164 (2009)2025

MAUDE reports naming product code DZE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074310711225
2008611184393
2009411103164
2010341623360
2011261940362
20123917411358
2013421951391
20143626571,124
20153621532,894
201640219151,116
20174822349,719
201841200412,892
2019312318167,016
2020412300255,524
2021341826479,618
2022342430483,224
2023352480537,585
2024402221473,629
2025311841465,788
2026151942—

What is it indicated for?

The Alpha-Bio Dental implant System® isindicated for use in surgical and restorative applications for placement in the bone of the upper or lowerjaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function, Two stage: ATID, DI, SPI, 8FB, ATIE OF, ITO, SPR One stage: ITO, SPR One stage and One Piece: ARRP, ARPB, ARRC 3 mm diameter implants are intended only for the incisors and cuspids of the…

Read the full statement (185 words)

The Alpha-Bio Dental implant System® isindicated for use in surgical and restorative applications for placement in the bone of the upper or lowerjaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function,

Two stage: ATID, DI, SPI, 8FB, ATIE OF, ITO, SPR

One stage: ITO, SPR

One stage and One Piece: ARRP, ARPB, ARRC 3 mm diameter implants are intended only for the incisors and cuspids of the maxilla and mandible they are also Indicated for denture stabilization using multiple implants

One stage and One Piece for temporary or long-term use: ARR, ARB, ARS, ARBS are self tapping titanium threaded screws indicated for long term intr bony applications. They permit immedate splint stabilty and longterm fixation of new or existing crown, bridge and pro:heths, and protection o graft sites

DFI, SPI, ARRP, ARPB and ARRC designs are Indicated for immediate loading when good primary stability is achieved and with appropriate occiusal loading.

SPI and $FB designs are hidIlated for irhmediatt loading in single tooth restorations when good primary stabity is achieved and with appropriate cddiusai loading.

Indications for use as stated in the FDA summary.

Also cleared against K022009

12 other devices cite the same predicate.

  • K082800Star/Vent Internal Hex Screw ImplantPark Dental Research Corp. · 2010
  • K073622Easy Grip Dental Implant SystemT.F.I. System S.R.L · 2008
  • K062636Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP, Microminiplant, Dental ImplantsImplant Innovations, Inc. · 2007
  • K0633413I Osseotite Certain Dental ImplantsImplant Innovations, Inc. · 200710 recalls
  • K063286Osseotite; Osseotite NT; XP; TG OsseotiteImplant Innovations, Inc. · 20075 recalls
  • K052254Mytis Arrow XXXXBrainbase Corporation · 2006

More from Alpha-Bio Tec, Ltd.

3 FDA decisions under this applicant name. See the company

  • K063769Alpha Bio Bone Fixation Screw SystemAlpha-Bio Tec, Ltd. · 2007
  • K063770Alpha-Bio Orthodontic Fixation Screw SystemAlpha-Bio Tec, Ltd. · 2007

Recent decisions in DZE

The DZE category page

  • K261295MultiNeO Dental Implant SystemAlpha Bio Tec, Ltd. · 2026
  • K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC · 2026
  • K260463ZEROS Dental Implant SystemZeros Co., Ltd. · 2026
  • K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd. · 2026
  • K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd. · 2026

https://510kreport.com/device/K063364 · printed Nov 6, 2026

Cite this page

510(k) Report. “K063364: Alpha Bio Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063364

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026