510(k) · Cleared

Cleared

Zimmer Dental One Piece Tapered Abutment, Models TAC1, TACW1, TA5C1

K060880510(k) SpecialCleared May 17, 200647-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

Zimmer Dental, Inc. · NHA Abutment, Implant, Dental, Endosseous

Cleared on May 17, 2006 after a 47-day review. The FDA summary names its predicate without a number. 242 later devices descend from it.

Decided: May 17, 2006
Review: 47 days
Class: Class II
Product code: NHA
Recalls: None
Predicates: 0

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

This deviceK060880 Zimmer Dental One Piece Tapered Abutment, Models TAC1, TACW1, TA5C1Zimmer Dental, Inc. · 2006
Descendant · cites it directly · 240 of its ownK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
Descendant · 2 generations on · 165 of its ownK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
Descendant · 3 generations on · 129 of its ownK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
Descendant · 3 generations on · 89 of its ownK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
Descendant · 4 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017

Showing 5 of 242 descendants. See all descendants

Descendants cleared per year

2010high 34 (2024) · low 2 (2010)2026

Most influential descendants

Showing 5 of 242 · See all

K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010 · cites it directly240descendants
K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG · 2012 · 2 generations on165descendants
K150203Medentika CAD/CAM AbutmentsMedentika GmbH · 2015 · 3 generations on129descendants
K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015 · 3 generations on89descendants
K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 4 generations on86descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K060880	Zimmer Dental One Piece Tapered Abutment, Models TAC1, TACW1, TA5C1	Zimmer Dental, Inc.	2006	—
+1	K100152	Sirona Cad/Cam System	Sirona Dental Systems GmbH	2010	—
+2	K120822	Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN…	Institut Straumann AG	2012	—
+3	K150203	Medentika CAD/CAM Abutments	Medentika GmbH	2015	—
+3	K150367	Neodent Implant System	Jjgc Industria E Comercio DE Materiais Dentarios S	2015	—
+4	K170588	DESS Dental Smart Solutions	Terrats Medical SL	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	2	0
2011	2	0
2012	3	0
2013	2	0
2014	7	0
2015	11	0
2016	12	0
2017	10	0
2018	13	0
2019	13	0
2020	20	0
2021	22	0
2022	19	0
2023	31	0
2024	34	0
2025	27	0
2026	14	0

FIG. 1 — Lineage of K060880, 2006–2026Source: 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 30.7 · 19 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? (2)

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
*	—	Zimmer Dental 3.5mm Hex-Lock Abutment (cat. No. HLA3/3) Named without a submission number			—
*	—	Zimmer Dental Tapered Abutment (cat. No. TAC2) Named without a submission number			—

What descends from it? (242)

See all 242

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

Number	Device	Applicant	Decided	Descendants
K100152	Sirona Cad/Cam System	Sirona Dental Systems GmbH	2010	240
K111421	Sirona Dental Cad/Cam System	Sirona Dental Systems GmbH	2012	54
K090081	Talladium International Implantology Abutments	Talladium Espana, SL	2010	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?

Of its descendants, K100152 (Sirona Dental Systems GmbH, 2010) has gone furthest, with 240 descendants of its own.

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?

The Zimmer Dental One Piece Tapered Abutment is intended for use in multiple unit screw retained restorations.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060880 · printed Nov 3, 2026

Cite this page

510(k) Report. “K060880: Zimmer Dental One Piece Tapered Abutment, Models TAC1, TACW1, TA5C1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K060880

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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