510(k) · Cleared

Cleared

17 Angulated Abutment

K961736510(k) TraditionalCleared Jul 18, 199676-day reviewClass II21 CFR 872.3630

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nobelpharma USA, Inc. · NHA Abutment, Implant, Dental, Endosseous

Cleared on Jul 18, 1996 as substantially equivalent to K944962 (Nobelpharma USA, Inc., 1995) after a 76-day review. Its family tree reaches back 1 generation to 1995. 8 later devices descend from it.

Decided: Jul 18, 1996
Review: 76 days
Class: Class II
Product code: NHA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K944962 (1995). 8 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK944962 Branemark System 17 Angulated AbutmentNobelpharma USA, Inc. · 1995
This deviceK961736 17 Angulated AbutmentNobelpharma USA, Inc. · 1996
Descendant · cites it directly · 7 of its ownK200992 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2020
Descendant · 2 generations on · 5 of its ownK211921 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2021
Descendant · 3 generations on · 4 of its ownK222231 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2022 · Recalled
Descendant · 3 generations on · 1 of its ownK221453 S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A. · 2022
Descendant · 2 generations on · 0 of its ownK252266 S.I.N. Dental Implant SystemS.I.N. Implant System Ltda · 2025

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2020high 3 (2025) · low 0 (2024)2026

Most influential descendants

Showing 5 of 8 · See all

K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2020 · cites it directly7descendants
K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2021 · 2 generations on5descendants
K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2022 · 3 generations on4descendants
K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A. · 2022 · 3 generations on1descendant
K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda · 2025 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K944962	Branemark System 17 Angulated Abutment	Nobelpharma USA, Inc.	1995	—
0 (this device)	K961736	17 Angulated Abutment	Nobelpharma USA, Inc.	1996	—
+1	K200992	S.I.N. Dental Implant System	S.I.N. - Sistema DE Implante Nacional S.A.	2020	—
+2	K211921	S.I.N. Dental Implant System	S.I.N. - Sistema DE Implante Nacional S.A.	2021	—
+3	K222231	S.I.N. Dental Implant System	S.I.N. - Sistema DE Implante Nacional S.A.	2022	1
+3	K221453	S.I.N. Dental Implant System	S.I.N. – Sistema DE Implante Nacional S.A.	2022	—
+2	K252266	S.I.N. Dental Implant System	S.I.N. Implant System Ltda	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2020	1	0
2021	1	0
2022	2	0
2023	1	0
2025	3	0

FIG. 1 — Lineage of K961736, 1995–2025Source: 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 NHA? 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 NHA device

#1 K222288 DESS Dental Smart Solutionsscore 30.7 · 19 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
*	K944962	Branemark System 17 Angulated Abutment Summary page 1 …ment to an endosseous implant with the trade name BRANEMARK SYSTEM® 17° Angulated Abutment. This submission is a modification to an previously cleared device subject to K944962. C. The Predicate Product The predicate product used in this Premarket Notification is the previous version of the same device,…	Nobelpharma USA, Inc.	1995	—

Also cleared against K944962: 2 other devices →

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K200992	S.I.N. Dental Implant System	S.I.N. - Sistema DE Implante Nacional S.A.	2020	7

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, K200992 (S.I.N. - Sistema DE Implante Nacional S.A., 2020) has gone furthest, with 7 descendants of its own.
2 other devices also cite its predicate K944962.

How does its category compare?

All NHA devices

NHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NHA

40in 2025

2007high 51 (2023) · low 19 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NHA

147in 2025

2007high 211 (2021) · low 90 (2008)2026

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

Recalls per year · NHA

1in 2025

2007high 36 (2016) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NHA

838in 2025

2007high 858 (2015) · low 1 (2007)2025

MAUDE reports naming product code NHA, 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	38	91	1	1
2008	31	90	2	8
2009	30	95	0	30
2010	19	162	0	61
2011	31	130	5	56
2012	25	171	1	5
2013	22	184	1	143
2014	27	160	0	146
2015	29	151	1	858
2016	38	202	36	314
2017	31	188	2	577
2018	31	200	1	591
2019	28	160	0	530
2020	38	153	7	458
2021	29	211	0	546
2022	33	142	0	497
2023	51	147	3	618
2024	43	158	0	635
2025	40	147	1	838
2026	23	169	3	—

What is it indicated for?

Intended to be used in edentulous patients as

an anchor to support a prosthesis.

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/K961736 · printed Nov 4, 2026

Cite this page

510(k) Report. “K961736: 17 Angulated Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961736

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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