510(k) Report

510(k) · Cleared

Cleared

Biohorizons Single-Stage Implant System

K073282510(k) TraditionalCleared Feb 15, 200886-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

BioHorizons Implant Systems, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Feb 15, 2008 as substantially equivalent to K053152 (BioHorizons Implant Systems, Inc., 2005) and 1 other predicate after an 86-day review. Its family tree reaches back 9 generations to 1996. 76 later devices descend from it.

Decided
Feb 15, 2008
Review
86 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
2

Its longest line of descent runs back 9 generations to K960026 (1996). 12 ancestors in all. 76 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2001: 1 other ancestor1999: 1 other ancestor2013: 2 descendants cleared2010: 1 descendant cleared2014: 5 descendants cleared2011: 2 descendants cleared2012: 1 descendant cleared2021: 6 descendants cleared2019: 5 descendants cleared2015: 2 descendants cleared2016: 5 descendants cleared2017: 2 descendants cleared2024: 7 descendants cleared2022: 9 descendants cleared2020: 6 descendants cleared2018: 2 descendants cleared2023: 7 descendants cleared2025: 9 descendants cleared2026: 5 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 · recalledK042429 · The Prodigy System Dental Implants · BioHorizons Implant Systems, Inc. · 2004K053152 · Biohorizons Single-Stage Implant · BioHorizons Implant Systems, Inc. · 2005 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor3 generations back: 1 other ancestor5 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 4 descendants4 generations forward: 14 descendants5 generations forward: 19 descendants6 generations forward: 14 descendants7 generations forward: 13 descendants8 generations forward: 4 descendants9 generations forward: 3 descendants K053152 · Biohorizons Single-Stage Implant · BioHorizons Implant Systems, Inc. · 2005 · recalledK042429 · The Prodigy System Dental Implants · BioHorizons Implant Systems, Inc. · 2004K030463 · 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
  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 backK042429 The Prodigy System Dental ImplantsBioHorizons Implant Systems, Inc. · 2004
  5. 1 generation backK053152 Biohorizons Single-Stage ImplantBioHorizons Implant Systems, Inc. · 2005 · Recalled
  6. This deviceK073282 Biohorizons Single-Stage Implant SystemBioHorizons Implant Systems, Inc. · 2008
  7. Descendant · cites it directly · 73 of its ownK100985 Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc. · 2010
  8. Descendant · 2 generations on · 45 of its ownK103691 Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · Recalled
  9. Descendant · 3 generations on · 36 of its ownK112440 AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012
  10. Descendant · 2 generations on · 30 of its ownK103291 Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc. · 2011
  11. Descendant · 3 generations on · 29 of its ownK122295 Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L. · 2013
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 backK042429 The Prodigy System Dental ImplantsBioHorizons Implant Systems, Inc. · 2004
  9. 1 generation backK053152 Biohorizons Single-Stage ImplantBioHorizons Implant Systems, Inc. · 2005 · Recalled
  10. This deviceK073282 Biohorizons Single-Stage Implant SystemBioHorizons Implant Systems, Inc. · 2008

Showing 5 of 76 descendants. See all descendants

Descendants cleared per year

2010: 12011: 22012: 12013: 22014: 52015: 22016: 52017: 22018: 22019: 52020: 62021: 62022: 92023: 72024: 72025: 92026: 5
2010high 9 (2022) · low 1 (2010)2026

Most influential descendants

Showing 5 of 76 · See all
  • K100985Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc. · 2010 · cites it directly73descendants
  • K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · 2 generations on45descendants
  • K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012 · 3 generations on36descendants
  • K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc. · 2011 · 2 generations on30descendants
  • K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L. · 2013 · 3 generations on29descendants
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
−2K042429The Prodigy System Dental ImplantsBioHorizons Implant Systems, Inc.2004—
−1K053152Biohorizons Single-Stage ImplantBioHorizons Implant Systems, Inc.20051
0 (this device)K073282Biohorizons Single-Stage Implant SystemBioHorizons Implant Systems, Inc.2008—
+1K100985Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc.2010—
+2K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.20111
+3K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.2012—
+2K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.2011—
+3K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200110
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201120
201210
201320
201450
201520
201650
201720
201820
201950
202060
202160
202290
202370
202470
202590
202650
FIG. 1 — Lineage of K073282, 1996–2026Source: 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? (2)

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
*K053152Biohorizons Single-Stage Implant
Summary page 1
…ous dental implant O!gsification Number: Class 11 (21 CFR 872.3640) _Rdicate Devices 1 iHorizons Single-stage Implant System, documented under 510(k) number 'k053152, concurrence date of December 2, 2005. 2-: ipHorizons Tapered Internal Implant System, documented under 510(k) number ..K071638…
BioHorizons Implant Systems, Inc.20051
*K071638Biohorizons Tapered Internal Implant System
Summary page 1
…em, documented under 510(k) number 'k053152, concurrence date of December 2, 2005. 2-: ipHorizons Tapered Internal Implant System, documented under 510(k) number ..K071638, concurrence date of October 10, 2007. ce Description ri~zons Single-stage Implants are machined titanium, screw-form en…
BioHorizons Implant Systems, Inc.20072

Also cleared against K053152: 1 other device →

What descends from it? (76)

See all 76

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

NumberDeviceApplicantDecidedDescendants
K100985Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc.201073
K133613Intra-Lock Dental ImplantsIntra-Lock International, Inc.20140
K131526Sfi-BarCendres & Metaux SA20130

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 12 years and passes through 1 company; a new generation was cleared every 10 months on median.
  • 3 of the 12 ancestors have a recall of any class.
  • Of its descendants, K100985 (BioHorizons Implant Systems, Inc., 2010) has gone furthest, with 73 descendants of its own.
  • 1 other device also cites its predicate K053152.

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. 2008, 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?

BioHorizons Single-stage Implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental restorations.

BioHorizons Single-stage Implants may be restored immediately with a temporary prosthesis that is not in functional occlusion, or when splinted together for multiple tooth replacement, or when stabilized with an overdenture supported by multiple implants.

Indications for use as stated in the FDA summary.

Also cleared against K053152

1 other device cites the same predicate.

  • K131526Sfi-BarCendres & Metaux SA · 2013

More from BioHorizons Implant Systems, Inc.

41 FDA decisions under this applicant name. See the company

  • K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc. · 2026
  • K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc. · 2025
  • K240531SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank AbutmentBioHorizons Implant Systems, Inc. · 2024
  • K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc. · 2024
  • K223697MRI compatibility for existing BioHorizons dental implants and abutmentsBioHorizons Implant Systems, Inc. · 20231 recall

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/K073282 · printed Nov 6, 2026

Cite this page

510(k) Report. “K073282: Biohorizons Single-Stage 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/K073282

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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