510(k) Report

510(k) · Cleared

Cleared

3I Dental Implants

K030614510(k) TraditionalCleared Sep 15, 2003201-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

Implant Innovations, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Sep 15, 2003 as substantially equivalent to K860653 (Otc/America, 1986) and 25 other predicates after a 201-day review. Its family tree reaches back 4 generations to 1993. 319 later devices descend from it.

Decided
Sep 15, 2003
Review
201 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
26

Its longest line of descent runs back 4 generations to K925765 (1993). 55 ancestors in all, the oldest K781060 (1978). 319 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 2 other ancestors2000: 2 other ancestors1999: 3 other ancestors1998: 3 other ancestors1997: 4 other ancestors1996: 5 other ancestors1995: 4 other ancestors1994: 6 other ancestors1990: 5 other ancestors1989: 5 other ancestors1988: 1 other ancestor1987: 2 other ancestors1986: 2 other ancestors2001: 2 other ancestors1992: 2 other ancestors1985: 1 other ancestor1982: 1 other ancestor1978: 1 other ancestor2007: 6 descendants cleared2005: 2 descendants cleared2004: 1 descendant cleared2008: 6 descendants cleared2013: 8 descendants cleared2011: 6 descendants cleared2010: 1 descendant cleared2015: 12 descendants cleared2018: 13 descendants cleared2014: 11 descendants cleared2012: 4 descendants cleared2017: 14 descendants cleared2009: 2 descendants cleared2016: 14 descendants cleared2022: 31 descendants cleared2026: 22 descendants cleared2023: 32 descendants cleared2020: 19 descendants cleared2024: 40 descendants cleared2021: 19 descendants cleared2019: 18 descendants cleared2025: 38 descendants clearedK925765 · Branemark System Standard 3.75MM Fixture · Nobelpharma USA, Inc. · 1993K994376 · Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2 3.4MM Steeped Cylinder Implant with Frios HA · Friadent GmbH · 2000K014235 · Osseotite NT Dental Implants & Accessories · Implant Innovations, Inc. · 2002K022009 · 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants · Implant Innovations, Inc. · 200219801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 23 other ancestors2 generations back: 27 other ancestors3 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 9 descendants3 generations forward: 27 descendants4 generations forward: 93 descendants5 generations forward: 84 descendants6 generations forward: 55 descendants7 generations forward: 29 descendants8 generations forward: 11 descendants9 generations forward: 5 descendants10 generations forward: 2 descendants11 generations forward: 1 descendant K022009 · 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants · Implant Innovations, Inc. · 2002K014235 · Osseotite NT Dental Implants & Accessories · Implant Innovations, Inc. · 2002K994376 · Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2 3.4MM Steeped Cylinder Implant with Frios HA · Friadent GmbH · 2000K925765 · Branemark System Standard 3.75MM Fixture · Nobelpharma USA, Inc. · 19930+5+10
  1. Root · 4 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
  2. 3 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
  3. 2 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
  4. 1 generation backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
  5. This deviceK030614 3I Dental ImplantsImplant Innovations, Inc. · 2003
  6. Descendant · cites it directly · 318 of its ownK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
  7. Descendant · 2 generations on · 317 of its ownK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
  8. Descendant · cites it directly · 312 of its ownK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
  9. Descendant · 2 generations on · 211 of its ownK063286 Osseotite; Osseotite NT; XP; TG OsseotiteImplant Innovations, Inc. · 2007 · Recalled
  10. Descendant · 2 generations on · 209 of its ownK063341 3I Osseotite Certain Dental ImplantsImplant Innovations, Inc. · 2007 · Recalled

Showing 5 of 319 descendants. See all descendants

Descendants cleared per year

2004: 12005: 22007: 62008: 62009: 22010: 12011: 62012: 42013: 82014: 112015: 122016: 142017: 142018: 132019: 182020: 192021: 192022: 312023: 322024: 402025: 382026: 22
2004high 40 (2024) · low 0 (2006)2026

Most influential descendants

Showing 5 of 319 · See all
  • K041402Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004 · cites it directly318descendants
  • K051189Prevail Dental ImplantsImplant Innovations, Inc. · 2005 · 2 generations on317descendants
  • K0514613I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005 · cites it directly312descendants
  • K063286Osseotite; Osseotite NT; XP; TG OsseotiteImplant Innovations, Inc. · 2007 · 2 generations on211descendants
  • K0633413I Osseotite Certain Dental ImplantsImplant Innovations, Inc. · 2007 · 2 generations on209descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K925765Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc.1993—
−3K994376Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2…Friadent GmbH2000—
−2K014235Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc.2002—
−1K0220093I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc.2002—
0 (this device)K0306143I Dental ImplantsImplant Innovations, Inc.2003—
+1K041402Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc.2004—
+2K051189Prevail Dental ImplantsImplant Innovations, Inc.2005—
+1K0514613I Osseotite Dental ImplantsImplant Innovations, Inc.2005—
+2K063286Osseotite; Osseotite NT; XP; TG OsseotiteImplant Innovations, Inc.20075
+2K0633413I Osseotite Certain Dental ImplantsImplant Innovations, Inc.200710

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198210
198510
198620
198720
198810
198950
199050
199220
199460
199540
199650
199740
199830
199930
200020
200120
200220

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200520
200760
200860
200920
201010
201160
201240
201380
2014110
2015120
2016140
2017140
2018130
2019180
2020190
2021190
2022310
2023320
2024400
2025380
2026220
FIG. 1 — Lineage of K030614, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (26)

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
*K860653Pure Titanium Screw-Type for Dental Implant
Summary page 1
…cation: 111 Classification Panels: Dental Regulation Number: 872.3640 Predicate Device(s) 3i Dental Implants (K8606531,K874590, K935544,K950204, K955428, K972444, K983347, KO 14235, K022009) 3i Abutments/Accessori…
Otc/America1986—
*K874590Innovative Implants and Cover Screws
Summary page 1
…11 Classification Panels: Dental Regulation Number: 872.3640 Predicate Device(s) 3i Dental Implants (K8606531,K874590, K935544,K950204, K955428, K972444, K983347, KO 14235, K022009) 3i Abutments/Accessories…
Implant Innovations International, Inc.1988—
*K9355443I Standard Threaded/Self-Tapping Threaded Implants Modification
Summary page 1
…Classification Panels: Dental Regulation Number: 872.3640 Predicate Device(s) 3i Dental Implants (K8606531,K874590, K935544,K950204, K955428, K972444, K983347, KO 14235, K022009) 3i Abutments/Accessories…
Implant Innovations International, Inc.1995—
*K9502043I Standard Threaded/Self-Tapping Threaded Implants, Miniplants (TM)
Summary page 1
…Classification Panels: Dental Regulation Number: 872.3640 Predicate Device(s) 3i Dental Implants (K8606531,K874590, K935544,K950204, K955428, K972444, K983347, KO 14235, K022009) 3i Abutments/Accessories K87186…
Implant Innovations, Inc.19952
*K9554283I Hydroxylapatite Coated Standard Threaded & Self-Tapping Implants
Summary page 1
…fication Panels: Dental Regulation Number: 872.3640 Predicate Device(s) 3i Dental Implants (K8606531,K874590, K935544,K950204, K955428, K972444, K983347, KO 14235, K022009) 3i Abutments/Accessories K871863, K87195…
Implant Innovations, Inc.1996—
*K9724443I Innovative Implants and Cover Screws
Summary page 1
…Panels: Dental Regulation Number: 872.3640 Predicate Device(s) 3i Dental Implants (K8606531,K874590, K935544,K950204, K955428, K972444, K983347, KO 14235, K022009) 3i Abutments/Accessories K871863, K871954, K89161…
Implant Innovations, Inc.19972
*K983347Osseotite Dental Implants
Summary page 1
…ental Regulation Number: 872.3640 Predicate Device(s) 3i Dental Implants (K8606531,K874590, K935544,K950204, K955428, K972444, K983347, KO 14235, K022009) 3i Abutments/Accessories K871863, K871954, K891613, K89546…
Implant Innovations, Inc.1999—
*K014235Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc.2002—
*K0220093I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants
Summary page 1
…mber: 872.3640 Predicate Device(s) 3i Dental Implants (K8606531,K874590, K935544,K950204, K955428, K972444, K983347, KO 14235, K022009) 3i Abutments/Accessories K871863, K871954, K891613, K895462, K895463, K904228, K934126,…
Implant Innovations, Inc.2002—
*K871863Adbutment Cylinder and Screw
Summary page 1
…(K8606531,K874590, K935544,K950204, K955428, K972444, K983347, KO 14235, K022009) 3i Abutments/Accessories K871863, K871954, K891613, K895462, K895463, K904228, K934126, K933969, K933462, K932123, K951553, KO221 13…
Implant Innovations International, Inc.1987—
*K871954Abutment Head Post
Summary page 1
…(K8606531,K874590, K935544,K950204, K955428, K972444, K983347, KO 14235, K022009) 3i Abutments/Accessories K871863, K871954, K891613, K895462, K895463, K904228, K934126, K933969, K933462, K932123, K951553, KO221 13 Nob…
Implant Innovations International, Inc.1987—
*K891613Overdenture Attachment
Summary page 1
…531,K874590, K935544,K950204, K955428, K972444, K983347, KO 14235, K022009) 3i Abutments/Accessories K871863, K871954, K891613, K895462, K895463, K904228, K934126, K933969, K933462, K932123, K951553, KO221 13 Nobel Biocar…
Implant Innovations International, Inc.19896
*K895462Osseodent Dental Attachments
Summary page 1
…90, K935544,K950204, K955428, K972444, K983347, KO 14235, K022009) 3i Abutments/Accessories K871863, K871954, K891613, K895462, K895463, K904228, K934126, K933969, K933462, K932123, K951553, KO221 13 Nobel Biocare Branema…
Collagen Corp.1990—
*K895463Osseodent (R) Precision Dental Attachments
Summary page 1
…44,K950204, K955428, K972444, K983347, KO 14235, K022009) 3i Abutments/Accessories K871863, K871954, K891613, K895462, K895463, K904228, K934126, K933969, K933462, K932123, K951553, KO221 13 Nobel Biocare Branemark System…
Collagen Corp.1990—
*K904228Osseodent Dental Attachments (Non-Angled)
Summary page 1
…4, K955428, K972444, K983347, KO 14235, K022009) 3i Abutments/Accessories K871863, K871954, K891613, K895462, K895463, K904228, K934126, K933969, K933462, K932123, K951553, KO221 13 Nobel Biocare Branemark System Implants…
Collagen Corp.19901
*K934126One and Two Piece Temporary Healing,(Emergence Profile) Abutments
Summary page 1
…8, K972444, K983347, KO 14235, K022009) 3i Abutments/Accessories K871863, K871954, K891613, K895462, K895463, K904228, K934126, K933969, K933462, K932123, K951553, KO221 13 Nobel Biocare Branemark System Implants (K992937…
Implant Innovations, Inc.19947
*K933969Tapered Abutment and Related Components
Summary page 1
…KO 14235, K022009) 3i Abutments/Accessories K871863, K871954, K891613, K895462, K895463, K904228, K934126, K933969, K933462, K932123, K951553, KO221 13 Nobel Biocare Branemark System Implants (K992937, K022562)…
Implant Innovations, Inc.1994—
*K933462Conical Abutment
Summary page 1
…KO 14235, K022009) 3i Abutments/Accessories K871863, K871954, K891613, K895462, K895463, K904228, K934126, K933969, K933462, K932123, K951553, KO221 13 Nobel Biocare Branemark System Implants (K992937, K022562) FRIADEN…
Implant Innovations, Inc.1994—
*K932123Implant Innovation Pre-Angled Abutment System
Summary page 1
…35, K022009) 3i Abutments/Accessories K871863, K871954, K891613, K895462, K895463, K904228, K934126, K933969, K933462, K932123, K951553, KO221 13 Nobel Biocare Branemark System Implants (K992937, K022562) FRIADENT FRIALIT…
Implant Innovations International, Inc.1994—
*K9515533I Asyst Abutment Package System
Summary page 1
…09) 3i Abutments/Accessories K871863, K871954, K891613, K895462, K895463, K904228, K934126, K933969, K933462, K932123, K951553, KO221 13 Nobel Biocare Branemark System Implants (K992937, K022562) FRIADENT FRIALIT-2 Implan…
Implant Innovations, Inc.1995—
*K0221133I Dental Implant AccessoriesImplant Innovations, Inc.2002—
*K992937Dental Implant
Summary page 1
…54, K891613, K895462, K895463, K904228, K934126, K933969, K933462, K932123, K951553, KO221 13 Nobel Biocare Branemark System Implants (K992937, K022562) FRIADENT FRIALIT-2 Implant (K994376) Straussmm IT1 Implant (K984104)…
Nobel Biocare Uas, Inc.20001
*K022562Various Branemark System Implants-Immediate Function Indication
Summary page 1
…13, K895462, K895463, K904228, K934126, K933969, K933462, K932123, K951553, KO221 13 Nobel Biocare Branemark System Implants (K992937, K022562) FRIADENT FRIALIT-2 Implant (K994376) Straussmm IT1 Implant (K984104) Dentatus…
Nobel Biocare AB2002—
*K994376Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2 3.4MM Steeped…
Summary page 1
…K933969, K933462, K932123, K951553, KO221 13 Nobel Biocare Branemark System Implants (K992937, K022562) FRIADENT FRIALIT-2 Implant (K994376) Straussmm IT1 Implant (K984104) Dentatus MTI Modular Transitional Implants (K980620) Performa…
Friadent GmbH2000—
*K984104Iti Dental Implant System
Summary page 1
…Nobel Biocare Branemark System Implants (K992937, K022562) FRIADENT FRIALIT-2 Implant (K994376) Straussmm IT1 Implant (K984104) Dentatus MTI Modular Transitional Implants (K980620) Performance Performance standards have not been esta…
Straumann USA19991
*K980620Dentatus Mti Modular Transitional Implants and Prosthetic System
Summary page 1
…2562) FRIADENT FRIALIT-2 Implant (K994376) Straussmm IT1 Implant (K984104) Dentatus MTI Modular Transitional Implants (K980620) Performance Performance standards have not been established by the FDA under section Standards 5 14 of the Federal,…
Dentatus USA, Ltd.1998—

What descends from it? (319)

See all 319

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

NumberDeviceApplicantDecidedDescendants
K041402Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc.2004318
K0514613I Osseotite Dental ImplantsImplant Innovations, Inc.2005312
K062636Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP…Implant Innovations, Inc.200728

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 10 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
  • 8 of the 55 ancestors have a recall of any class.
  • Of its descendants, K041402 (Implant Innovations, Inc., 2004) has gone furthest, with 318 descendants of its own.

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.

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?

3i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth, freestanding bridges and to retain overdentures.

In addition, when a minimum of 4 implants, 2 10 mm in length, are placed in the the mandible and splinted in the anterior region, immediate loading is indicated.

Indications for use as stated in the FDA summary.

More from Implant Innovations, Inc.

51 FDA decisions under this applicant name. See the company

  • 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
  • K063403Conical Angled AbutmentImplant Innovations, Inc. · 20075 recalls
  • K061629Certain Prevail Dental ImplantImplant Innovations, Inc. · 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/K030614 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030614: 3I Dental Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030614

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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