510(k) · Cleared

Cleared

P.004 Abutments

K071919510(k) TraditionalCleared Sep 26, 200776-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

Straumann USA (On Behalf of Institut Straumann Ag) · NHA Abutment, Implant, Dental, Endosseous

Cleared on Sep 26, 2007 as substantially equivalent to K062129 (Institut Straumann AG, 2006) and 2 other predicates after a 76-day review. Its family tree reaches back 6 generations to 1990.

Decided: Sep 26, 2007
Review: 76 days
Class: Class II
Product code: NHA
Recalls: None
Predicates: 3

Its longest line of descent runs back 6 generations to K894844 (1990). 9 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 6 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
5 generations backK990342 Synocta ProstheticsStraumann USA · 1999
4 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
3 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
2 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
1 generation backK062129 P.0004 ImplantsInstitut Straumann AG · 2006
This deviceK071919 P.004 AbutmentsStraumann USA (On Behalf of Institut Straumann Ag) · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K894844	Bonefit Implant System Accessories & Instruments	Straumann Institute, Ltd.	1990	—
−5	K990342	Synocta Prosthetics	Straumann USA	1999	—
−4	K013798	Prosthetic Accessories to the Iti Dental Implant System	Institut Straumann AG	2001	—
−3	K020096	Esthetic Ease Abutments for the Iti Dental Implant System	Institut Straumann AG	2002	1
−2	K033243	Iti Synocta Meso Abutments	Straumann USA	2003	—
−1	K062129	P.0004 Implants	Institut Straumann AG	2006	—
0 (this device)	K071919	P.004 Abutments	Straumann USA (On Behalf of Institut Straumann Ag)	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
2001	2	0

FIG. 1 — Lineage of K071919, 1990–2007Source: 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? (3)

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
*	K062129	P.0004 Implants Summary page 1 …r: §872.3630 :3. Legally Marketed Device to which Equivalence is Claimed (Predicate Device) Straumann P.004 Dental Implants, K062129 RN synOcta® Gold Coping, K990342 RN synOcta® Titanium Coping, K990342 RN Abutment for Bars, K894844 -…	Institut Straumann AG	2006	—
*	K990342	Synocta Prosthetics Summary page 1 …Legally Marketed Device to which Equivalence is Claimed (Predicate Device) Straumann P.004 Dental Implants, K062129 RN synOcta® Gold Coping, K990342 RN synOcta® Titanium Coping, K990342 RN Abutment for Bars, K894844 -4. Description of the Device…	Straumann USA	1999	—
*	K894844	Bonefit Implant System Accessories & Instruments Summary page 1 …Straumann P.004 Dental Implants, K062129 RN synOcta® Gold Coping, K990342 RN synOcta® Titanium Coping, K990342 RN Abutment for Bars, K894844 -4. Description of the Device The Straumann P.004 Dental Implant System is an integrated system of endos…	Straumann Institute, Ltd.	1990	—

Also cleared against K062129: 30 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 17 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
1 of the 9 ancestors has a recall of any class.
30 other devices also cite its predicate K062129.

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. 2007, 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?

Both the P.004 RCINC Gold Abutment for Bars and RC/NC Titanium Abutment for Bars are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071919 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071919: P.004 Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071919

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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