510(k) · Cleared

Cleared

Replace HA Coated Implants

K962845510(k) TraditionalCleared Oct 18, 199688-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 Oct 18, 1996 after an 88-day review. The FDA summary names its predicate without a number. 644 later devices descend from it.

Decided: Oct 18, 1996
Review: 88 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 0

644 later devices descend from it, 4 citing it directly.

This deviceK962845 Replace HA Coated ImplantsSteri-Oss, Inc. · 1996
Descendant · cites it directly · 630 of its ownK020646 Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132…Nobel Biocare Uas, Inc. · 2002
Descendant · 2 generations on · 625 of its ownK022424 Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132…Nobel Biocare Uas, Inc. · 2002
Descendant · 3 generations on · 622 of its ownK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
Descendant · 4 generations on · 532 of its ownK050705 Tiunite ImplantsNobel Biocare AB · 2005 · Recalled
Descendant · 4 generations on · 511 of its ownK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled

Showing 5 of 644 descendants. See all descendants

Descendants cleared per year

2001high 63 (2024) · low 1 (2001)2026

Most influential descendants

Showing 5 of 644 · 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

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K962845	Replace HA Coated Implants	Steri-Oss, Inc.	1996	—
+1	K020646	Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162…	Nobel Biocare Uas, Inc.	2002	—
+2	K022424	Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162…	Nobel Biocare Uas, Inc.	2002	—
+3	K041661	Nobel Biocare Endosseous Implants	Nobel Biocare Uas, Inc.	2004	—
+4	K050705	Tiunite Implants	Nobel Biocare AB	2005	1
+4	K050258	Groovy Implants	Nobel Biocare AB	2005	28

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	3	0
2003	2	0
2004	3	0
2005	6	0
2006	7	0
2007	8	0
2008	9	0
2009	8	0
2010	13	0
2011	18	0
2012	15	0
2013	27	0
2014	30	0
2015	35	0
2016	33	0
2017	30	0
2018	31	0
2019	34	0
2020	47	0
2021	44	0
2022	42	0
2023	54	0
2024	63	0
2025	54	0
2026	27	0

FIG. 1 — Lineage of K962845, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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? (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.

Type	Number	Device	Applicant	Decided	Recalls
*	—	Nobelpharma's 3.75 mm implant Named without a submission number			—

What descends from it? (644)

See all 644

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

Number	Device	Applicant	Decided	Descendants
K020646	Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162, 50102…	Nobel Biocare Uas, Inc.	2002	630
K021584	Replace Scalloped Margin Implant System	Nobel Biocare Uas, Inc.	2002	12
K031322	Intra-Lock Hydroxyapatite Coated Implants	Intra-Lock International	2003	0
K011574	Uniplant Dental Implant System	Universal Implant Systems, Inc.	2001	0

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, K020646 (Nobel Biocare Uas, Inc., 2002) has gone furthest, with 630 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	—

What is it indicated for?

The implant is indicated for use in restoring masticatory function in the edentulous and/or partially edentulous patient.

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

https://510kreport.com/device/K962845 · printed Nov 6, 2026

Cite this page

510(k) Report. “K962845: Replace HA Coated Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962845

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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