510(k) · Cleared

Cleared

Branemark System Healing Caps

K925780510(k) TraditionalCleared Apr 14, 1993149-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 Apr 14, 1993 after a 149-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 352 later devices descend from it.

Decided: Apr 14, 1993
Review: 149 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 0

352 later devices descend from it, 2 citing it directly.

This deviceK925780 Branemark System Healing CapsNobelpharma USA, Inc. · 1993
Descendant · cites it directly · 349 of its ownK962023 Plastic Protection Healing CapsThe Straumann Co. · 1996
Descendant · 2 generations on · 318 of its ownK051717 RN Synocta Temporary Meso AbutmentInstitut Straumann SA · 2005
Descendant · 3 generations on · 283 of its ownK070478 P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap)Straumann Manufacturing, Inc. · 2007
Descendant · 4 generations on · 279 of its ownK072679 P.004 AbutmentsInstitut Straumann AG · 2007
Descendant · 5 generations on · 223 of its ownK092814 Straumann Dental AbutmentsStraumann Manufacturing, Inc. · 2009

Showing 5 of 352 descendants. See all descendants

Descendants cleared per year

1996high 47 (2023) · low 0 (1997)2026

Most influential descendants

Showing 5 of 352 · See all

K962023Plastic Protection Healing CapsThe Straumann Co. · 1996 · cites it directly349descendants
K051717RN Synocta Temporary Meso AbutmentInstitut Straumann SA · 2005 · 2 generations on318descendants
K070478P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap)Straumann Manufacturing, Inc. · 2007 · 3 generations on283descendants
K072679P.004 AbutmentsInstitut Straumann AG · 2007 · 4 generations on279descendants
K092814Straumann Dental AbutmentsStraumann Manufacturing, Inc. · 2009 · 5 generations on223descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K925780	Branemark System Healing Caps	Nobelpharma USA, Inc.	1993	—
+1	K962023	Plastic Protection Healing Caps	The Straumann Co.	1996	—
+2	K051717	RN Synocta Temporary Meso Abutment	Institut Straumann SA	2005	—
+3	K070478	P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap)	Straumann Manufacturing, Inc.	2007	—
+4	K072679	P.004 Abutments	Institut Straumann AG	2007	—
+5	K092814	Straumann Dental Abutments	Straumann Manufacturing, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
2005	1	0
2006	2	0
2007	6	0
2008	4	0
2009	1	0
2010	1	0
2011	2	0
2012	5	0
2013	8	0
2014	10	0
2015	14	0
2016	16	0
2017	23	0
2018	22	0
2019	14	0
2020	28	0
2021	28	0
2022	25	0
2023	47	0
2024	45	0
2025	30	0
2026	19	0

FIG. 1 — Lineage of K925780, 1993–2026Source: 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? (352)

See all 352

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

Number	Device	Applicant	Decided	Descendants
K962023	Plastic Protection Healing Caps	The Straumann Co.	1996	349
K171142	Healing Cap Multi-Unit Titanium	Nobel Biocare AB	2017	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?

Of its descendants, K962023 (The Straumann Co., 1996) has gone furthest, with 349 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/K925780 · printed Nov 6, 2026

Cite this page

510(k) Report. “K925780: Branemark System Healing Caps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925780

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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