510(k) · Cleared

Cleared

Zimmer Dental Hex-Lock Prepared Abutment (Straight & Angled)

K052600510(k) SpecialCleared Oct 13, 200522-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 Oct 13, 2005 after a 22-day review. The FDA summary names its predicate without a number. 35 later devices descend from it.

Decided: Oct 13, 2005
Review: 22 days
Class: Class II
Product code: NHA
Recalls: None
Predicates: 0

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

This deviceK052600 Zimmer Dental Hex-Lock Prepared Abutment (Straight & Angled)Zimmer Dental, Inc. · 2005
Descendant · cites it directly · 25 of its ownK132125 A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014
Descendant · 2 generations on · 14 of its ownK140440 Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014
Descendant · cites it directly · 7 of its ownK200992 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2020
Descendant · 3 generations on · 7 of its ownK151909 Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016
Descendant · 2 generations on · 5 of its ownK211921 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2021

Showing 5 of 35 descendants. See all descendants

Descendants cleared per year

2014high 6 (2022) · low 0 (2015)2026

Most influential descendants

Showing 5 of 35 · See all

K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014 · cites it directly25descendants
K140440Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014 · 2 generations on14descendants
K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2020 · cites it directly7descendants
K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016 · 3 generations on7descendants
K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2021 · 2 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K052600	Zimmer Dental Hex-Lock Prepared Abutment (Straight & Angled)	Zimmer Dental, Inc.	2005	—
+1	K132125	A.B. Dental Devices Dental Implants System	A.B. Dental Devices, Ltd.	2014	—
+2	K140440	Noris Medical Dental Implants System	Noris Medical, Ltd.	2014	—
+1	K200992	S.I.N. Dental Implant System	S.I.N. - Sistema DE Implante Nacional S.A.	2020	—
+3	K151909	Noris Medical Zygomatic Dental Implant System	Noris Medical, Ltd.	2016	—
+2	K211921	S.I.N. Dental Implant System	S.I.N. - Sistema DE Implante Nacional S.A.	2021	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	4	0
2016	2	0
2017	1	0
2018	2	0
2019	4	0
2020	3	0
2021	3	0
2022	6	0
2023	1	0
2024	3	0
2025	4	0
2026	2	0

FIG. 1 — Lineage of K052600, 2005–2026Source: 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

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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
*	—	Zimmer Dental 3.5mm Hex-Lock Abutment Named without a submission number			—

What descends from it? (35)

See all 35

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

Number	Device	Applicant	Decided	Descendants
K132125	A.B. Dental Devices Dental Implants System	A.B. Dental Devices, Ltd.	2014	25
K200992	S.I.N. Dental Implant System	S.I.N. - Sistema DE Implante Nacional S.A.	2020	7
K142082	Zimmer 3.1MM Dental Implant;2.9MM Angled Abutment;Straight Hex, 2.9MM Contour Abutement	Zimmer Dental, Inc.	2014	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, K132125 (A.B. Dental Devices, Ltd., 2014) has gone furthest, with 25 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 Hex-Lock Prepared Straight Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. The Zimmer Dental Hex-Lock Prepared Angled Abutment is used as a terminal or intermediate abutment for a cemented prosthesis where the angle needs to be offset by 170. Either abutment can be used for a single or multiple-unit restoration.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052600 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052600: Zimmer Dental Hex-Lock Prepared Abutment (Straight & Angled).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052600

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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