510(k) · Cleared

Cleared

Steri-Oss Titanium Alloy Screw Series Implant for Single Stage Surgical Placement

K944158510(k) TraditionalCleared Mar 29, 1995215-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 Mar 29, 1995 after a 215-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 330 later devices descend from it.

Decided: Mar 29, 1995
Review: 215 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 0

330 later devices descend from it, 1 citing it directly.

This deviceK944158 Steri-Oss Titanium Alloy Screw Series Implant for Single Stage…Steri-Oss, Inc. · 1995
Descendant · cites it directly · 329 of its ownK963224 Steri-Oss Implants for Single Stage PlacementSteri-Oss, Inc. · 1996
Descendant · 2 generations on · 328 of its ownK041236 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004
Descendant · 3 generations on · 327 of its ownK043042 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004
Descendant · 3 generations on · 313 of its ownK090069 Procera Implant Bridge OverdentureNobel Biocare AB · 2009
Descendant · 4 generations on · 278 of its ownK091756 Nobelprocera TI AbutmentNobel Biocare AB · 2009

Showing 5 of 330 descendants. See all descendants

Descendants cleared per year

1996high 41 (2024) · low 0 (1997)2026

Most influential descendants

Showing 5 of 330 · See all

K963224Steri-Oss Implants for Single Stage PlacementSteri-Oss, Inc. · 1996 · cites it directly329descendants
K041236Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004 · 2 generations on328descendants
K043042Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004 · 3 generations on327descendants
K090069Procera Implant Bridge OverdentureNobel Biocare AB · 2009 · 3 generations on313descendants
K091756Nobelprocera TI AbutmentNobel Biocare AB · 2009 · 4 generations on278descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K944158	Steri-Oss Titanium Alloy Screw Series Implant for Single Stage Surgical…	Steri-Oss, Inc.	1995	—
+1	K963224	Steri-Oss Implants for Single Stage Placement	Steri-Oss, Inc.	1996	—
+2	K041236	Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052	Nobel Biocare AB	2004	—
+3	K043042	Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052	Nobel Biocare AB	2004	—
+3	K090069	Procera Implant Bridge Overdenture	Nobel Biocare AB	2009	—
+4	K091756	Nobelprocera TI Abutment	Nobel Biocare AB	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
2004	2	0
2006	1	0
2009	5	0
2010	4	0
2011	5	0
2012	7	0
2013	5	0
2014	14	0
2015	15	0
2016	19	0
2017	17	0
2018	16	0
2019	17	0
2020	30	0
2021	27	0
2022	25	0
2023	33	0
2024	41	0
2025	29	0
2026	17	0

FIG. 1 — Lineage of K944158, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (330)

See all 330

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

Number	Device	Applicant	Decided	Descendants
K963224	Steri-Oss Implants for Single Stage Placement	Steri-Oss, Inc.	1996	329

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, K963224 (Steri-Oss, Inc., 1996) has gone furthest, with 329 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

2007high 61 (2008) · low 26 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DZE

184in 2025

2007high 265 (2014) · low 107 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DZE

1in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	43	107	11	225
2008	61	118	4	393
2009	41	110	3	164
2010	34	162	3	360
2011	26	194	0	362
2012	39	174	11	358
2013	42	195	1	391
2014	36	265	7	1,124
2015	36	215	3	2,894
2016	40	219	15	1,116
2017	48	223	4	9,719
2018	41	200	4	12,892
2019	31	231	8	167,016
2020	41	230	0	255,524
2021	34	182	6	479,618
2022	34	243	0	483,224
2023	35	248	0	537,585
2024	40	222	1	473,629
2025	31	184	1	465,788
2026	15	194	2	—

https://510kreport.com/device/K944158 · printed Nov 5, 2026

Cite this page

510(k) Report. “K944158: Steri-Oss Titanium Alloy Screw Series Implant for Single Stage Surgical Placement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K944158

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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