510(k) Report

510(k) · Cleared

Cleared

3I Hydroxylapatite Coated Standard Threaded & Self-Tapping Implants

K955428510(k) TraditionalCleared Feb 8, 199672-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 Feb 8, 1996 after a 72-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 324 later devices descend from it.

Decided
Feb 8, 1996
Review
72 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
0

324 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2008: 7 descendants cleared2007: 6 descendants cleared2003: 1 descendant cleared2005: 2 descendants cleared2004: 2 descendants cleared2013: 8 descendants cleared2011: 6 descendants cleared2012: 5 descendants cleared2014: 11 descendants cleared2010: 1 descendant cleared2015: 12 descendants cleared2018: 14 descendants cleared2017: 14 descendants cleared2009: 2 descendants cleared2016: 14 descendants cleared2022: 31 descendants cleared2019: 18 descendants cleared2026: 22 descendants cleared2023: 32 descendants cleared2020: 19 descendants cleared2024: 40 descendants cleared2021: 19 descendants cleared2025: 38 descendants cleared1995200020052010201520202025
  1. This deviceK955428 3I Hydroxylapatite Coated Standard Threaded & Self-Tapping ImplantsImplant Innovations, Inc. · 1996
  2. Descendant · cites it directly · 319 of its ownK030614 3I Dental ImplantsImplant Innovations, Inc. · 2003
  3. Descendant · 2 generations on · 318 of its ownK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
  4. Descendant · 3 generations on · 317 of its ownK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
  5. Descendant · cites it directly · 312 of its ownK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
  6. Descendant · 2 generations on · 211 of its ownK063286 Osseotite; Osseotite NT; XP; TG OsseotiteImplant Innovations, Inc. · 2007 · Recalled

Showing 5 of 324 descendants. See all descendants

Descendants cleared per year

2003: 12004: 22005: 22007: 62008: 72009: 22010: 12011: 62012: 52013: 82014: 112015: 122016: 142017: 142018: 142019: 182020: 192021: 192022: 312023: 322024: 402025: 382026: 22
2003high 40 (2024) · low 0 (2006)2026

Most influential descendants

Showing 5 of 324 · See all
  • K0306143I Dental ImplantsImplant Innovations, Inc. · 2003 · cites it directly319descendants
  • K041402Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004 · 2 generations on318descendants
  • K051189Prevail Dental ImplantsImplant Innovations, Inc. · 2005 · 3 generations on317descendants
  • K0514613I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005 · cites it directly312descendants
  • K063286Osseotite; Osseotite NT; XP; TG OsseotiteImplant Innovations, Inc. · 2007 · 2 generations on211descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K9554283I Hydroxylapatite Coated Standard Threaded & Self-Tapping ImplantsImplant Innovations, Inc.1996—
+1K0306143I Dental ImplantsImplant Innovations, Inc.2003—
+2K041402Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc.2004—
+3K051189Prevail Dental ImplantsImplant Innovations, Inc.2005—
+1K0514613I Osseotite Dental ImplantsImplant Innovations, Inc.2005—
+2K063286Osseotite; Osseotite NT; XP; TG OsseotiteImplant Innovations, Inc.20075

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200420
200520
200760
200870
200920
201010
201160
201250
201380
2014110
2015120
2016140
2017140
2018140
2019180
2020190
2021190
2022310
2023320
2024400
2025380
2026220
FIG. 1 — Lineage of K955428, 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (324)

See all 324

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

NumberDeviceApplicantDecidedDescendants
K0306143I Dental ImplantsImplant Innovations, Inc.2003319
K0514613I Osseotite Dental ImplantsImplant Innovations, Inc.2005312
K062636Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP…Implant Innovations, Inc.200728
K073070Dio Biotite-H Implant SystemDio Department Dsi, Inc.200816
K042339Neoplant Implant SystemNeobiotech Co., Ltd.20040

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?

  • Of its descendants, K030614 (Implant Innovations, Inc., 2003) has gone furthest, with 319 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—

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/K955428 · printed Nov 4, 2026

Cite this page

510(k) Report. “K955428: 3I Hydroxylapatite Coated Standard Threaded & Self-Tapping Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955428

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026