510(k) · Cleared

Cleared

Cera One Abutment System

K961737510(k) TraditionalCleared Jul 10, 199668-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

Nobelpharma USA, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Jul 10, 1996 as substantially equivalent to K910611 (Nobelpharma USA, Inc., 1991) after a 68-day review. Its family tree reaches back 1 generation to 1991. 550 later devices descend from it.

Decided: Jul 10, 1996
Review: 68 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K910611 (1991). 550 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK910611 Nobelpharma Ceraone Abutment SystemNobelpharma USA, Inc. · 1991
This deviceK961737 Cera One Abutment SystemNobelpharma USA, Inc. · 1996
Descendant · cites it directly · 549 of its ownK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
Descendant · cites it directly · 545 of its ownK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
Descendant · 2 generations on · 543 of its ownK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
Descendant · 3 generations on · 476 of its ownK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
Descendant · 3 generations on · 441 of its ownK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004

Showing 5 of 550 descendants. See all descendants

Descendants cleared per year

1996high 60 (2024) · low 0 (1999)2026

Most influential descendants

Showing 5 of 550 · See all

K962403Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996 · cites it directly549descendants
K971706Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997 · cites it directly545descendants
K974150Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · 2 generations on543descendants
K0322633I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · 3 generations on476descendants
K042658Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004Nobel Biocare Uas, Inc. · 2004 · 3 generations on441descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K910611	Nobelpharma Ceraone Abutment System	Nobelpharma USA, Inc.	1991	—
0 (this device)	K961737	Cera One Abutment System	Nobelpharma USA, Inc.	1996	—
+1	K962403	Noblepharma Wide Accessories	Nobelpharma USA, Inc.	1996	—
+1	K971706	Tiadapt Abutment System	Nobel Biocare Uas, Inc.	1997	—
+2	K974150	Procera Preparable Abutment System	Nobel Biocare Uas, Inc.	1998	2
+3	K032263	3I Patient-Specific Dental Abutment and Overdenture Bar	Implant Innovations, Inc.	2004	1
+3	K042658	Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004…	Nobel Biocare Uas, Inc.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1997	2	0
1998	1	0
2004	6	0
2005	4	0
2006	7	0
2007	5	0
2008	7	0
2009	14	0
2010	9	0
2011	15	0
2012	14	0
2013	15	0
2014	21	0
2015	27	0
2016	33	0
2017	26	0
2018	27	0
2019	24	0
2020	42	0
2021	39	0
2022	37	0
2023	45	0
2024	60	0
2025	43	0
2026	26	0

FIG. 1 — Lineage of K961737, 1991–2026Source: 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

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K910611	Nobelpharma Ceraone Abutment System Summary page 1 …n abutment to an endosseous implant with the trade name BRANEMARK SYSTEM® CeraOne Abutment System. This submission is a modification to a previously cleared device under K910611. C. The Predicate Product The predicate product used in this Premarket Notification is the previous version of the same device,…	Nobelpharma USA, Inc.	1991	—

Also cleared against K910611: 4 other devices →

What descends from it? (550)

See all 550

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

Number	Device	Applicant	Decided	Descendants
K962403	Noblepharma Wide Accessories	Nobelpharma USA, Inc.	1996	549
K971706	Tiadapt Abutment System	Nobel Biocare Uas, Inc.	1997	545
K972475	Auradapt Aubtment System	Nobel Biocare Uas, Inc.	1997	2

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, K962403 (Nobelpharma USA, Inc., 1996) has gone furthest, with 549 descendants of its own.
4 other devices also cite its predicate K910611.

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 Nobelpharma CeraOne Abutment System is intended to be used

to anchor single tooth prostheses in partially edentulous patients.

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/K961737 · printed Nov 5, 2026

Cite this page

510(k) Report. “K961737: Cera One Abutment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961737

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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