510(k) · Cleared

Cleared

Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping

K061277510(k) TraditionalCleared Apr 12, 2007339-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 · NHA Abutment, Implant, Dental, Endosseous

Cleared on Apr 12, 2007 as substantially equivalent to K052272 (Straumann USA, 2006) and 4 other predicates after a 339-day review. Its family tree reaches back 6 generations to 1990. 265 later devices descend from it.

Decided: Apr 12, 2007
Review: 339 days
Class: Class II
Product code: NHA
Recalls: None
Predicates: 5

Its longest line of descent runs back 6 generations to K894844 (1990). 10 ancestors in all. 265 later devices descend from it, 4 citing it directly.

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 backK052272 Straumann Computer Aided Restoration ServiceStraumann USA · 2006
This deviceK061277 Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic…Straumann USA · 2007
Descendant · cites it directly · 264 of its ownK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
Descendant · 2 generations on · 263 of its ownK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
Descendant · 3 generations on · 240 of its ownK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
Descendant · cites it directly · 171 of its ownK082545 Straumann NN Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008
Descendant · cites it directly · 169 of its ownK093113 Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG · 2009

Showing 5 of 265 descendants. See all descendants

Descendants cleared per year

2007high 36 (2024) · low 1 (2007)2026

Most influential descendants

Showing 5 of 265 · See all

K072151P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · cites it directly264descendants
K081005P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · 2 generations on263descendants
K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010 · 3 generations on240descendants
K082545Straumann NN Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · cites it directly171descendants
K093113Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG · 2009 · cites it directly169descendants

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	K052272	Straumann Computer Aided Restoration Service	Straumann USA	2006	—
0 (this device)	K061277	Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping	Straumann USA	2007	—
+1	K072151	P.004 RC Cares Titanium and Ceramic Abutments	Straumann USA	2007	1
+2	K081005	P.004 NC Cares Titanium and Ceramic Abutments	Institut Straumann AG	2008	1
+3	K100152	Sirona Cad/Cam System	Sirona Dental Systems GmbH	2010	—
+1	K082545	Straumann NN Cares Titanium and Ceramic Abutments	Institut Straumann AG	2008	—
+1	K093113	Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam Abutment	Institut Straumann AG	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
2001	1	0
2002	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	2	0
2009	1	0
2010	2	0
2011	4	0
2012	3	0
2013	3	0
2014	9	0
2015	13	0
2016	13	0
2017	12	0
2018	15	0
2019	14	0
2020	21	0
2021	23	0
2022	19	0
2023	32	0
2024	36	0
2025	28	0
2026	14	0

FIG. 1 — Lineage of K061277, 1990–2026Source: 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

Get a 510(k) Report

What was it cleared against? (5)

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
*	K052272	Straumann Computer Aided Restoration Service Summary page 1 …21 CFR 872.3630 3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) Straumann C.A.R.E.S. Titanium Abutment, K052272 Straumann's synOcta® Meso Abutment, K033243 Vident Ceramic Hextop Abutment and synOcta® In-Ceram Coping, K012473 ITI 1.5…	Straumann USA	2006	—
*	K033243	Iti Synocta Meso Abutments Summary page 1 …3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) Straumann C.A.R.E.S. Titanium Abutment, K052272 Straumann's synOcta® Meso Abutment, K033243 Vident Ceramic Hextop Abutment and synOcta® In-Ceram Coping, K012473 ITI 1.5 mm synOcta Abutment, K022859 and synOcta Ab…	Straumann USA	2003	—
*	K012473	Vident Hextop, Synocta in-Ceram Blank/Coping Manufactured by Vident Summary page 1 …evices) Straumann C.A.R.E.S. Titanium Abutment, K052272 Straumann's synOcta® Meso Abutment, K033243 Vident Ceramic Hextop Abutment and synOcta® In-Ceram Coping, K012473 ITI 1.5 mm synOcta Abutment, K022859 and synOcta Abutments and Prosthetic Accessories, K990342 4. Description of the Devic…	Vident	2002	—
*	K022859	Abutment and Prosthetic Accessories to the Iti Dental Implant System Summary page 1 …Abutment, K052272 Straumann's synOcta® Meso Abutment, K033243 Vident Ceramic Hextop Abutment and synOcta® In-Ceram Coping, K012473 ITI 1.5 mm synOcta Abutment, K022859 and synOcta Abutments and Prosthetic Accessories, K990342 4. Description of the Device The Straumann Dental Implant Syste…	Straumann USA	2002	—
*	K990342	Synocta Prosthetics Summary page 1 …3243 Vident Ceramic Hextop Abutment and synOcta® In-Ceram Coping, K012473 ITI 1.5 mm synOcta Abutment, K022859 and synOcta Abutments and Prosthetic Accessories, K990342 4. Description of the Device The Straumann Dental Implant System is an integrated system of endosseous dental implants de…	Straumann USA	1999	—

Also cleared against K052272: 7 other devices →

What descends from it? (265)

See all 265

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

Number	Device	Applicant	Decided	Descendants
K072151	P.004 RC Cares Titanium and Ceramic Abutments	Straumann USA	2007	264
K082545	Straumann NN Cares Titanium and Ceramic Abutments	Institut Straumann AG	2008	171
K093113	Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam Abutment	Institut Straumann AG	2009	169
K150899	Straumann CARES Titanium Alloy (TAN) Abutment	Straumann USA, LLC	2015	11

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 3 companies; a new generation was cleared every 2.2 years on median.
1 of the 10 ancestors has a recall of any class.
Of its descendants, K072151 (Straumann USA, 2007) has gone furthest, with 264 descendants of its own.
7 other devices also cite its predicate K052272.

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?

Copings are intended to provide support for prosthetic reconstructions such as crowns or bridges. The Straumann C.A.R.E.S. Ceramic Coping is indicated for cemented restorations. The coping can be used in single tooth replacements and multiple tooth restorations.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061277 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061277: Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061277

Report an extraction error

Are you the manufacturer?

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