510(k) · Cleared

Recalled · Class II · 2021

Nobelprocera Angulated Screw Channel Abutment Conical Connection

K132746510(k) TraditionalCleared Jan 30, 2014149-day reviewClass II21 CFR 872.3630Recalls 5

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nobel Biocare USA, LLC · NHA Abutment, Implant, Dental, Endosseous

Cleared on Jan 30, 2014 after a 149-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 17 later devices descend from it. It has been recalled 5 times.

Decided: Jan 30, 2014
Review: 149 days
Class: Class II
Product code: NHA
Recalls: 5
Predicates: 0

17 later devices descend from it, 4 citing it directly.

This deviceK132746 Nobelprocera Angulated Screw Channel Abutment Conical ConnectionNobel Biocare USA, LLC · 2014
Descendant · cites it directly · 10 of its ownK161655 On1 ConceptNobel Biocare AB · 2017
Descendant · 2 generations on · 6 of its ownK181869 On1 Universal AbutmentNobel Biocare AB · 2018
Descendant · 3 generations on · 4 of its ownK202344 TiUltra Implants and Xeal AbutmentsNobel Biocare AB · 2020
Descendant · cites it directly · 3 of its ownK160158 NobelProcera HT ML FCZ Implant Bridge and FrameworkNobel Biocare AB · 2016
Descendant · cites it directly · 2 of its ownK233208 NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw TitaniumNobel Biocare AB · 2024

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2016high 3 (2024) · low 0 (2019)2026

Most influential descendants

Showing 5 of 17 · See all

K161655On1 ConceptNobel Biocare AB · 2017 · cites it directly10descendants
K181869On1 Universal AbutmentNobel Biocare AB · 2018 · 2 generations on6descendants
K202344TiUltra Implants and Xeal AbutmentsNobel Biocare AB · 2020 · 3 generations on4descendants
K160158NobelProcera HT ML FCZ Implant Bridge and FrameworkNobel Biocare AB · 2016 · cites it directly3descendants
K233208NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw TitaniumNobel Biocare AB · 2024 · cites it directly2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K132746	Nobelprocera Angulated Screw Channel Abutment Conical Connection	Nobel Biocare USA, LLC	2014	—
+1	K161655	On1 Concept	Nobel Biocare AB	2017	—
+2	K181869	On1 Universal Abutment	Nobel Biocare AB	2018	—
+3	K202344	TiUltra Implants and Xeal Abutments	Nobel Biocare AB	2020	—
+1	K160158	NobelProcera HT ML FCZ Implant Bridge and Framework	Nobel Biocare AB	2016	—
+1	K233208	NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium	Nobel Biocare AB	2024	—

Descendants by year cleared

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

FIG. 1 — Lineage of K132746, 2014–2026Source: 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 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (17)

See all 17

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

Number	Device	Applicant	Decided	Descendants
K161655	On1 Concept	Nobel Biocare AB	2017	10
K160158	NobelProcera HT ML FCZ Implant Bridge and Framework	Nobel Biocare AB	2016	3
K233208	NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium	Nobel Biocare AB	2024	2
K251220	NUVENTUS NV.C™ Prosthetic Components	Infinitum Eta, Ltd.	2025	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 29, 2021	Class II	Z-1680-2021	Process control	Not manufactured to specification
Mar 29, 2021	Class II	Z-1678-2021	Process control	Not manufactured to specification
Mar 29, 2021	Class II	Z-1681-2021	Process control	Not manufactured to specification
Mar 29, 2021	Class II	Z-1677-2021	Process control	Not manufactured to specification
Mar 29, 2021	Class II	Z-1679-2021	Process control	Not manufactured to specification

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K161655 (Nobel Biocare AB, 2017) has gone furthest, with 10 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. 2014, 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	—

https://510kreport.com/device/K132746 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132746: Nobelprocera Angulated Screw Channel Abutment Conical Connection.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132746

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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