510(k) · Cleared

Cleared

Branemark System 17 Angulated Abutment

K944962510(k) TraditionalCleared Feb 27, 1995143-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 Feb 27, 1995 after a 143-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 32 later devices descend from it.

Decided: Feb 27, 1995
Review: 143 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 0

32 later devices descend from it, 3 citing it directly.

This deviceK944962 Branemark System 17 Angulated AbutmentNobelpharma USA, Inc. · 1995
Descendant · cites it directly · 20 of its ownK052885 Zygoma 17 Abutment Multi-Unit RP 2MM, Model 29314; Zygoma 17…Nobel Biocare USA, LLC · 2005
Descendant · 2 generations on · 19 of its ownK070182 Zygoma Implant (Immediate Function)Nobel Biocare AB · 2007
Descendant · 3 generations on · 10 of its ownK093562 Endosseous Dental ImplantSouthern Implants, Inc. · 2010
Descendant · 3 generations on · 8 of its ownK141777 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
Descendant · cites it directly · 8 of its ownK961736 17 Angulated AbutmentNobelpharma USA, Inc. · 1996

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

1996high 4 (2022) · low 0 (1997)2026

Most influential descendants

Showing 5 of 32 · See all

K052885Zygoma 17 Abutment Multi-Unit RP 2MM, Model 29314; Zygoma 17 Abutment Multi-Unit RP 3MM…Nobel Biocare USA, LLC · 2005 · cites it directly20descendants
K070182Zygoma Implant (Immediate Function)Nobel Biocare AB · 2007 · 2 generations on19descendants
K093562Endosseous Dental ImplantSouthern Implants, Inc. · 2010 · 3 generations on10descendants
K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015 · 3 generations on8descendants
K96173617 Angulated AbutmentNobelpharma USA, Inc. · 1996 · cites it directly8descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K944962	Branemark System 17 Angulated Abutment	Nobelpharma USA, Inc.	1995	—
+1	K052885	Zygoma 17 Abutment Multi-Unit RP 2MM, Model 29314; Zygoma 17 Abutment…	Nobel Biocare USA, LLC	2005	—
+2	K070182	Zygoma Implant (Immediate Function)	Nobel Biocare AB	2007	—
+3	K093562	Endosseous Dental Implant	Southern Implants, Inc.	2010	—
+3	K141777	Neodent Implant System	Jjgc Industria E Comercio DE Materiais Dentarios S	2015	—
+1	K961736	17 Angulated Abutment	Nobelpharma USA, Inc.	1996	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
2005	1	0
2007	1	0
2010	1	0
2013	1	0
2015	2	0
2016	3	0
2017	1	0
2018	2	0
2019	2	0
2020	2	0
2021	2	0
2022	4	0
2023	2	0
2024	1	0
2025	4	0
2026	2	0

FIG. 1 — Lineage of K944962, 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (32)

See all 32

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

Number	Device	Applicant	Decided	Descendants
K052885	Zygoma 17 Abutment Multi-Unit RP 2MM, Model 29314; Zygoma 17 Abutment Multi-Unit RP 3MM…	Nobel Biocare USA, LLC	2005	20
K961736	17 Angulated Abutment	Nobelpharma USA, Inc.	1996	8
K123386	Periotype X-Pert	Clinical House Europe GmbH	2013	1

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, K052885 (Nobel Biocare USA, LLC, 2005) has gone furthest, with 20 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/K944962 · printed Nov 5, 2026

Cite this page

510(k) Report. “K944962: Branemark System 17 Angulated Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K944962

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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