510(k) Report

510(k) · Cleared

Recalled · Class II · 2024

Biohorizons Tapered Internal Implant System

K071638510(k) TraditionalCleared Oct 10, 2007117-day reviewClass II21 CFR 872.3640Recalls 2

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 Oct 10, 2007 after a 117-day review. The FDA summary names no predicate by number. 129 later devices descend from it. It has been recalled 2 times.

Decided
Oct 10, 2007
Review
117 days
Class
Class II
Product code
DZE
Recalls
2
Predicates
0

129 later devices descend from it, 12 citing it directly.

Descendants, by year cleared 2013: 5 descendants cleared2016: 9 descendants cleared2024: 10 descendants cleared2010: 2 descendants cleared2011: 5 descendants cleared2008: 2 descendants cleared2015: 5 descendants cleared2012: 2 descendants cleared2014: 6 descendants cleared2021: 11 descendants cleared2018: 6 descendants cleared2017: 9 descendants cleared2025: 9 descendants cleared2026: 6 descendants cleared2019: 7 descendants cleared2023: 11 descendants cleared2022: 14 descendants cleared2020: 10 descendants cleared20052010201520202025
  1. This deviceK071638 Biohorizons Tapered Internal Implant SystemBioHorizons Implant Systems, Inc. · 2007
  2. Descendant · cites it directly · 111 of its ownK073268 Biohorizons Internal Implant SystemBioHorizons Implant Systems, Inc. · 2008 · Recalled
  3. Descendant · cites it directly · 103 of its ownK093321 Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc. · 2010 · Recalled
  4. Descendant · cites it directly · 76 of its ownK073282 Biohorizons Single-Stage Implant SystemBioHorizons Implant Systems, Inc. · 2008
  5. Descendant · cites it directly · 73 of its ownK100985 Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc. · 2010
  6. Descendant · cites it directly · 45 of its ownK103691 Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · Recalled

Showing 5 of 129 descendants. See all descendants

Descendants cleared per year

2008: 22010: 22011: 52012: 22013: 52014: 62015: 52016: 92017: 92018: 62019: 72020: 102021: 112022: 142023: 112024: 102025: 92026: 6
2008high 14 (2022) · low 0 (2009)2026

Most influential descendants

Showing 5 of 129 · See all
  • K073268Biohorizons Internal Implant SystemBioHorizons Implant Systems, Inc. · 2008 · cites it directly111descendants
  • K093321Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc. · 2010 · cites it directly103descendants
  • K073282Biohorizons Single-Stage Implant SystemBioHorizons Implant Systems, Inc. · 2008 · cites it directly76descendants
  • K100985Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc. · 2010 · cites it directly73descendants
  • K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · cites it directly45descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K071638Biohorizons Tapered Internal Implant SystemBioHorizons Implant Systems, Inc.2007—
+1K073268Biohorizons Internal Implant SystemBioHorizons Implant Systems, Inc.20081
+1K093321Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc.20101
+1K073282Biohorizons Single-Stage Implant SystemBioHorizons Implant Systems, Inc.2008—
+1K100985Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc.2010—
+1K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.20111

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200820
201020
201150
201220
201350
201460
201550
201690
201790
201860
201970
2020100
2021110
2022140
2023110
2024100
202590
202660
FIG. 1 — Lineage of K071638, 2007–2026Source: 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?

The FDA summary names no predicate by number.

What descends from it? (129)

See all 129

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

NumberDeviceApplicantDecidedDescendants
K073268Biohorizons Internal Implant SystemBioHorizons Implant Systems, Inc.2008111
K093321Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc.2010103
K073282Biohorizons Single-Stage Implant SystemBioHorizons Implant Systems, Inc.200876
K100985Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc.201073
K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.201145
K121787Biohorizons Tapered Internal Plus ImplantsBioHorizons Implant Systems, Inc.201213
K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165
K143022BioHorizons Tapered Internal ImplantsBioHorizons Implant Systems, Inc.20154
K110577Osseofuse Dental Implant SystemDynamic Innovations, Inc.20114
K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242

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

Recalls of this device

DateClassRecallRoot causeReason
Dec 6, 2024Class IIZ-1111-2025Component design/selectionCertain definitive dental implant restoration cases may have included a temporary titanium abutment (cylinder), rather than a definitive titanium abutment, which may lead the titanium abutment fracture, which may risk loosening of the…
Apr 16, 2015Class IIZ-1605-2015Process controlBioHorizons Tapered HD Upgrade set was packaged with an incorrect drill component manufactured of stainless steel in place of the correct component manufactured from titanium.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K073268 (BioHorizons Implant Systems, Inc., 2008) has gone furthest, with 111 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. 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 BioHorizons Tapered Internal Implant System is intended for use in the mandible or maxilla for use as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention.

The BioHorizons Tapered Internal Implant System may be restored immediately

1) with a temporary prosthesis that is not in functional occlusion or

2) 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.

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/K071638 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071638: Biohorizons Tapered Internal Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071638

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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