510(k) · Cleared
ClearedStraumann Computer Aided Restoration Service
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Straumann USA · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jan 3, 2006 as substantially equivalent to K033243 (Straumann USA, 2003) after a 134-day review. Its family tree reaches back 5 generations to 1990. 268 later devices descend from it.
- Decided
- Jan 3, 2006
- Review
- 134 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K894844 (1990). 7 ancestors in all. 268 later devices descend from it, 8 citing it directly.
- Root · 5 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 4 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 3 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 2 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 1 generation backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- This deviceK052272 Straumann Computer Aided Restoration ServiceStraumann USA · 2006
- Descendant · cites it directly · 265 of its ownK061277 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
Showing 5 of 268 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 268 · See all- K061277Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic CopingStraumann USA · 2007 · cites it directly265descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −4 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −3 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −2 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −1 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| 0 (this device) | K052272 | Straumann Computer Aided Restoration Service | Straumann USA | 2006 | — |
| +1 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 3 | 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 | 13 | 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 |
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
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 | Decided |
|---|---|---|---|
| * | K033243 | Iti Synocta Meso AbutmentsSummary page 1…21 CFR 872.3640 3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) Straumann's synOcta Meso Abutment (K033243) 4. Description of the Device The Straumann Dental Implant System is an integrated system of endosseous dent… | 2003 |
What descends from it? (268)
See all 2688 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061277 | Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping | 2007 | 265 |
| K072151 | P.004 RC Cares Titanium and Ceramic Abutments | 2007 | 264 |
| K082545 | Straumann NN Cares Titanium and Ceramic Abutments | 2008 | 171 |
| K082764 | Straumann WN Cares Titanium Abutment | 2008 | 171 |
| K093113 | Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam Abutment | 2009 | 169 |
| K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann… | 2012 | 165 |
| K150203 | Medentika CAD/CAM Abutments | 2015 | 129 |
| K150367 | Neodent Implant System | 2015 | 89 |
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 16 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K061277 (Straumann USA, 2007) has gone furthest, with 265 descendants of its own.
- 6 other devices also cite its predicate K033243.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 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?
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The Straumann C.A.R.E.S. Titanium Abutment is indicated for cemented restorations. The abutment can be used in single tooth replacements and multiple tooth restorations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052272 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052272: Straumann Computer Aided Restoration Service.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052272
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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