510(k) Report

510(k) · Cleared

Cleared

Steri-Oss Implants for Single Stage Placement

K963224510(k) TraditionalCleared Nov 14, 199690-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 Nov 14, 1996 as substantially equivalent to K944158 (Steri-Oss, Inc., 1995) after a 90-day review. Its family tree reaches back 1 generation to 1995. 329 later devices descend from it.

Decided
Nov 14, 1996
Review
90 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K944158 (1995). 329 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 2 descendants cleared2010: 4 descendants cleared2009: 5 descendants cleared2006: 1 descendant cleared2011: 5 descendants cleared2014: 14 descendants cleared2013: 5 descendants cleared2016: 19 descendants cleared2012: 7 descendants cleared2024: 41 descendants cleared2018: 16 descendants cleared2015: 15 descendants cleared2017: 17 descendants cleared2023: 33 descendants cleared2022: 25 descendants cleared2020: 30 descendants cleared2021: 27 descendants cleared2019: 17 descendants cleared2026: 17 descendants cleared2025: 29 descendants clearedK944158 · Steri-Oss Titanium Alloy Screw Series Implant for Single Stage Surgical Placement · Steri-Oss, Inc. · 19951995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 10 descendants4 generations forward: 29 descendants5 generations forward: 68 descendants6 generations forward: 85 descendants7 generations forward: 65 descendants8 generations forward: 34 descendants9 generations forward: 13 descendants10 generations forward: 12 descendants11 generations forward: 6 descendants12 generations forward: 1 descendant13 generations forward: 1 descendant K944158 · Steri-Oss Titanium Alloy Screw Series Implant for Single Stage Surgical Placement · Steri-Oss, Inc. · 19950+5+10
  1. Root · 1 generation backK944158 Steri-Oss Titanium Alloy Screw Series Implant for Single Stage…Steri-Oss, Inc. · 1995
  2. This deviceK963224 Steri-Oss Implants for Single Stage PlacementSteri-Oss, Inc. · 1996
  3. Descendant · cites it directly · 328 of its ownK041236 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004
  4. Descendant · 2 generations on · 327 of its ownK043042 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004
  5. Descendant · 2 generations on · 313 of its ownK090069 Procera Implant Bridge OverdentureNobel Biocare AB · 2009
  6. Descendant · 3 generations on · 278 of its ownK091756 Nobelprocera TI AbutmentNobel Biocare AB · 2009
  7. Descendant · 4 generations on · 240 of its ownK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010

Showing 5 of 329 descendants. See all descendants

Descendants cleared per year

2004: 22006: 12009: 52010: 42011: 52012: 72013: 52014: 142015: 152016: 192017: 172018: 162019: 172020: 302021: 272022: 252023: 332024: 412025: 292026: 17
2004high 41 (2024) · low 0 (2005)2026

Most influential descendants

Showing 5 of 329 · See all
  • K041236Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004 · cites it directly328descendants
  • K043042Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004 · 2 generations on327descendants
  • K090069Procera Implant Bridge OverdentureNobel Biocare AB · 2009 · 2 generations on313descendants
  • K091756Nobelprocera TI AbutmentNobel Biocare AB · 2009 · 3 generations on278descendants
  • K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010 · 4 generations on240descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K944158Steri-Oss Titanium Alloy Screw Series Implant for Single Stage Surgical…Steri-Oss, Inc.1995—
0 (this device)K963224Steri-Oss Implants for Single Stage PlacementSteri-Oss, Inc.1996—
+1K041236Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB2004—
+2K043042Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB2004—
+2K090069Procera Implant Bridge OverdentureNobel Biocare AB2009—
+3K091756Nobelprocera TI AbutmentNobel Biocare AB2009—
+4K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
200610
200950
201040
201150
201270
201350
2014140
2015150
2016190
2017170
2018160
2019170
2020300
2021270
2022250
2023330
2024410
2025290
2026170
FIG. 1 — Lineage of K963224, 1995–2026Source: 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? (1)

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
*K944158Steri-Oss Titanium Alloy Screw Series Implant for Single Stage Surgical Placement
Summary page 1
…i-Oss’ Oss’ “Titanium Alloy Screw Series Implant For Single Stage Surgical Placement (“SSP”)". an uncoated 3.8-mm diameter threaded titanium alloy implant (510(k) number K944158, Steri-Oss catalog numbers 2208, 2210, 2212, 2214, 2216, and 2218). Device Description: 1) How The Device Functions: Steri-Oss…
Steri-Oss, Inc.1995—

What descends from it? (329)

See all 329

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

NumberDeviceApplicantDecidedDescendants
K041236Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB2004328

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, K041236 (Nobel Biocare AB, 2004) has gone furthest, with 328 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?

Steri-Oss Single Stage Surgical Placement implants are intended to serve as support for prosthetic devices to restore patient chewing function and are surgically placed using the single stage surgical placement method.

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

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
  • K973423Steri-Oss 3.25 MM Replace (Hydroxyapatite-Coated)Dental ImplantSteri-Oss, Inc. · 1997
  • K973402Steri-Oss 3.25 MM Replace Dental Implant SystemSteri-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/K963224 · printed Nov 6, 2026

Cite this page

510(k) Report. “K963224: Steri-Oss Implants for Single Stage Placement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963224

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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