510(k) · Cleared

Cleared

NobelPerfect Abutments

K172854510(k) TraditionalCleared Dec 14, 201785-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

Nobel Biocare AB · NHA Abutment, Implant, Dental, Endosseous

Cleared on Dec 14, 2017 as substantially equivalent to K021584 (Nobel Biocare Uas, Inc., 2002) after an 85-day review. Its family tree reaches back 2 generations to 1996.

Decided: Dec 14, 2017
Review: 85 days
Class: Class II
Product code: NHA
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K962845 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK962845 Replace HA Coated ImplantsSteri-Oss, Inc. · 1996
1 generation backK021584 Replace Scalloped Margin Implant SystemNobel Biocare Uas, Inc. · 2002
This deviceK172854 NobelPerfect AbutmentsNobel Biocare AB · 2017

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K962845	Replace HA Coated Implants	Steri-Oss, Inc.	1996	—
−1	K021584	Replace Scalloped Margin Implant System	Nobel Biocare Uas, Inc.	2002	—
0 (this device)	K172854	NobelPerfect Abutments	Nobel Biocare AB	2017	—

FIG. 1 — Lineage of K172854, 1996–2017Source: 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
*	K021584	Replace Scalloped Margin Implant System Summary page 4 …ame: Endosseous Dental Implant (21 CFR 872.3630) Regulatory Class: II Product Code: NHA III.PREDICATE DEVICE Primary Predicate Replace Scalloped Margin Implant System (K021584) Reference Predicate: TREFOIL System (K170135) NobelActive Wide Platform (K133731) IV. DEVICE DESCRIPTION The NobelPerfect Abu…	Nobel Biocare Uas, Inc.	2002	—
†	K170135	TREFOIL System	Nobel Biocare AB	2017	—
†	K133731	Nobelactive Wide Platform (WP)	Nobel Biocare AB	2014	—

Also cleared against K021584: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 15.5 years on median.
None of the 2 ancestors has a recall.
5 other devices also cite its predicate K021584.

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. 2017, this device’s year, is highlighted.

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 NobelPerfect Abutments are pre-manufactured prosthetic components directly connected to the endosseous dental implant and are intended for use as an aid in prosthetic rehabilitation.

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/K172854 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172854: NobelPerfect Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172854

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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