510(k) · Cleared

Cleared

Miruscone Abutment System

K961728510(k) TraditionalCleared Jul 10, 199668-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 10, 1996 as substantially equivalent to K944964 (Nobelpharma USA, Inc., 1995) after a 68-day review. Its family tree reaches back 1 generation to 1995. 551 later devices descend from it.

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

Its longest line of descent runs back 1 generation to K944964 (1995). 551 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
This deviceK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
Descendant · cites it directly · 549 of its ownK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
Descendant · 2 generations on · 545 of its ownK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
Descendant · 3 generations on · 543 of its ownK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
Descendant · 4 generations on · 476 of its ownK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
Descendant · 4 generations on · 441 of its ownK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004

Showing 5 of 551 descendants. See all descendants

Descendants cleared per year

1996high 60 (2024) · low 0 (1999)2026

Most influential descendants

Showing 5 of 551 · See all

K962403Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996 · cites it directly549descendants
K971706Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997 · 2 generations on545descendants
K974150Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · 3 generations on543descendants
K0322633I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · 4 generations on476descendants
K042658Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004Nobel Biocare Uas, Inc. · 2004 · 4 generations on441descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K944964	Branemark System Miruscone Abutment System	Nobelpharma USA, Inc.	1995	—
0 (this device)	K961728	Miruscone Abutment System	Nobelpharma USA, Inc.	1996	—
+1	K962403	Noblepharma Wide Accessories	Nobelpharma USA, Inc.	1996	—
+2	K971706	Tiadapt Abutment System	Nobel Biocare Uas, Inc.	1997	—
+3	K974150	Procera Preparable Abutment System	Nobel Biocare Uas, Inc.	1998	2
+4	K032263	3I Patient-Specific Dental Abutment and Overdenture Bar	Implant Innovations, Inc.	2004	1
+4	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	3	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 K961728, 1995–2026Source: 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 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 30.6 · 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
*	K944964	Branemark System Miruscone Abutment System Summary page 1 …s an abutment to an endosseous implant with the trade name BRANEMARK SYSTEM® MirusCone Abutment System. This submission is a modification to a previously cleared device, K944964. C. The Predicate Product The predicate product used in this Premarket Noitification is the previous version of the same device…	Nobelpharma USA, Inc.	1995	—

Also cleared against K944964: 1 other device →

What descends from it? (551)

See all 551

5 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
K041655	Bio Plant System (Implants and Abutments)	Cowellmedi Co., Ltd.	2004	91
K052369	Exfeel Implant System	Megagen Co., Ltd.	2006	84
K050635	Allfim Implant Systems	Cowellmedi Co., Ltd.	2005	5
K965135	Lifecore Conical Abutment	Lifecore Biomedical, Inc.	1997	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?

Its one ancestor has no recall.
Of its descendants, K962403 (Nobelpharma USA, Inc., 1996) has gone furthest, with 549 descendants of its own.
1 other device also cites its predicate K944964.

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/K961728 · printed Nov 6, 2026

Cite this page

510(k) Report. “K961728: Miruscone Abutment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961728

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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