510(k) Report

510(k) · Cleared

Cleared

Steri-Oss 3.25 MM Replace (Hydroxyapatite-Coated)Dental Implant

K973423510(k) TraditionalCleared Dec 5, 199786-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

Steri-Oss, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Dec 5, 1997 as substantially equivalent to K911592 (Steri-Oss, Inc., 1993) after an 86-day review. Its family tree reaches back 1 generation to 1993. 631 later devices descend from it.

Decided
Dec 5, 1997
Review
86 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K911592 (1993). 631 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2002: 2 descendants cleared2015: 35 descendants cleared2011: 18 descendants cleared2006: 7 descendants cleared2004: 1 descendant cleared2012: 15 descendants cleared2016: 33 descendants cleared2024: 63 descendants cleared2019: 34 descendants cleared2008: 9 descendants cleared2005: 4 descendants cleared2013: 26 descendants cleared2014: 30 descendants cleared2018: 31 descendants cleared2023: 54 descendants cleared2025: 54 descendants cleared2026: 27 descendants cleared2010: 13 descendants cleared2009: 7 descendants cleared2022: 42 descendants cleared2017: 29 descendants cleared2020: 47 descendants cleared2021: 44 descendants cleared2007: 6 descendants clearedK911592 · Steri-Oss Titanium Plama Spray Cylindrical Implant · Steri-Oss, Inc. · 19931990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 6 descendants4 generations forward: 15 descendants5 generations forward: 40 descendants6 generations forward: 93 descendants7 generations forward: 128 descendants8 generations forward: 97 descendants9 generations forward: 82 descendants10 generations forward: 74 descendants11 generations forward: 44 descendants12 generations forward: 24 descendants13 generations forward: 13 descendants14 generations forward: 3 descendants15 generations forward: 5 descendants16 generations forward: 2 descendants K911592 · Steri-Oss Titanium Plama Spray Cylindrical Implant · Steri-Oss, Inc. · 19930+5+10+15
  1. Root · 1 generation backK911592 Steri-Oss Titanium Plama Spray Cylindrical ImplantSteri-Oss, Inc. · 1993
  2. This deviceK973423 Steri-Oss 3.25 MM Replace (Hydroxyapatite-Coated)Dental ImplantSteri-Oss, Inc. · 1997
  3. Descendant · cites it directly · 630 of its ownK020646 Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132…Nobel Biocare Uas, Inc. · 2002
  4. Descendant · 2 generations on · 625 of its ownK022424 Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132…Nobel Biocare Uas, Inc. · 2002
  5. Descendant · 3 generations on · 622 of its ownK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
  6. Descendant · 4 generations on · 532 of its ownK050705 Tiunite ImplantsNobel Biocare AB · 2005 · Recalled
  7. Descendant · 4 generations on · 511 of its ownK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled

Showing 5 of 631 descendants. See all descendants

Descendants cleared per year

2002: 22004: 12005: 42006: 72007: 62008: 92009: 72010: 132011: 182012: 152013: 262014: 302015: 352016: 332017: 292018: 312019: 342020: 472021: 442022: 422023: 542024: 632025: 542026: 27
2002high 63 (2024) · low 0 (2003)2026

Most influential descendants

Showing 5 of 631 · See all
  • K020646Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162, 50102…Nobel Biocare Uas, Inc. · 2002 · cites it directly630descendants
  • K022424Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162, 50102…Nobel Biocare Uas, Inc. · 2002 · 2 generations on625descendants
  • K041661Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004 · 3 generations on622descendants
  • K050705Tiunite ImplantsNobel Biocare AB · 2005 · 4 generations on532descendants
  • K050258Groovy ImplantsNobel Biocare AB · 2005 · 4 generations on511descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K911592Steri-Oss Titanium Plama Spray Cylindrical ImplantSteri-Oss, Inc.1993—
0 (this device)K973423Steri-Oss 3.25 MM Replace (Hydroxyapatite-Coated)Dental ImplantSteri-Oss, Inc.1997—
+1K020646Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162…Nobel Biocare Uas, Inc.2002—
+2K022424Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162…Nobel Biocare Uas, Inc.2002—
+3K041661Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc.2004—
+4K050705Tiunite ImplantsNobel Biocare AB20051
+4K050258Groovy ImplantsNobel Biocare AB200528

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200410
200540
200670
200760
200890
200970
2010130
2011180
2012150
2013260
2014300
2015350
2016330
2017290
2018310
2019340
2020470
2021440
2022420
2023540
2024630
2025540
2026270
FIG. 1 — Lineage of K973423, 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? (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
*K911592Steri-Oss Titanium Plama Spray Cylindrical Implant
Summary page 1
…stantial equivalence is claimed to Steri-Oss’ (Hydroxyapatite-coated) Replace Implants and to Steri-Oss’ (3.25 mm diameter) Titanium Plasma Sprayed Cylindrical implant (K911592). Page 1 of 3 Steri-Oss Inc. - September 1997 Original 510(k) Steri-Oss 3.25 mm Replace (Hydroxyapatite-Coated)…
Steri-Oss, Inc.1993—
*—Steri-Oss’ (Hydroxyapatite-coated) Replace Implants
Named without a submission number
—

Also cleared against K911592: 1 other device →

What descends from it? (631)

See all 631

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K020646Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162, 50102…Nobel Biocare Uas, Inc.2002630

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?

  • Its one ancestor has no recall.
  • Of its descendants, K020646 (Nobel Biocare Uas, Inc., 2002) has gone furthest, with 630 descendants of its own.
  • 1 other device also cites its predicate K911592.

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?

The intended use for this device is to serve as support for prosthetic devices to restore patient chewing function.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K911592

1 other device cites the same predicate.

  • K973402Steri-Oss 3.25 MM Replace Dental Implant SystemSteri-Oss, Inc. · 1997

More from Steri-Oss, Inc.

46 FDA decisions under this applicant name. See the company

  • K982400Steri-Oss' Improv Temporary Dental CementSteri-Oss, Inc. · 1998
  • K980439Replace Cylindrical ImplantsSteri-Oss, Inc. · 1998
  • K973433Steri-Oss 3.25 MM Replace (Titanium Plasma Sprayed) Dental ImplantSteri-Oss, Inc. · 1997
  • K973402Steri-Oss 3.25 MM Replace Dental Implant SystemSteri-Oss, Inc. · 1997
  • K972965Steri-Oss Until Implant CementSteri-Oss, Inc. · 1997

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/K973423 · printed Nov 4, 2026

Cite this page

510(k) Report. “K973423: Steri-Oss 3.25 MM Replace (Hydroxyapatite-Coated)Dental Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973423

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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