510(k) · Cleared
ClearedStraumann CARES Titanium Alloy (TAN) Abutment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Straumann USA, LLC · NHA Abutment, Implant, Dental, Endosseous
Cleared on Sep 16, 2015 as substantially equivalent to K061277 (Straumann USA, 2007) and 2 other predicates after a 166-day review. Its family tree reaches back 9 generations to 1990. 11 later devices descend from it.
- Decided
- Sep 16, 2015
- Review
- 166 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K894844 (1990). 15 ancestors in all. 11 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 5 generations between
- 3 generations backK061277 Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic…Straumann USA · 2007
- 2 generations backK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
- 1 generation backK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- This deviceK150899 Straumann CARES Titanium Alloy (TAN) AbutmentStraumann USA, LLC · 2015
- Descendant · cites it directly · 5 of its ownK162890 BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and…Straumann USA, LLC · 2017
- Descendant · cites it directly · 3 of its ownK171649 Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG · 2018
- Descendant · 2 generations on · 1 of its ownK231395 INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK192893 Straumann Ceramic Healing AbutmentsInstitut Straumann AG · 2020
- Descendant · 3 generations on · 0 of its ownK251605 DIMPLO Implant SystemDIMPLO, Ltd. · 2025
Show all 9 generations
- Root · 9 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 8 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 7 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 6 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 5 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 4 generations backK052272 Straumann Computer Aided Restoration ServiceStraumann USA · 2006
- 3 generations backK061277 Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic…Straumann USA · 2007
- 2 generations backK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
- 1 generation backK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- This deviceK150899 Straumann CARES Titanium Alloy (TAN) AbutmentStraumann USA, LLC · 2015
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC · 2017 · cites it directly5descendants
- K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG · 2018 · cites it directly3descendants
- K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd. · 2023 · 2 generations on1descendant
- K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG · 2020 · 2 generations on1descendant
- K251605DIMPLO Implant SystemDIMPLO, Ltd. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −8 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −7 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −6 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −5 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −4 | K052272 | Straumann Computer Aided Restoration Service | Straumann USA | 2006 | — |
| −3 | K061277 | Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping | Straumann USA | 2007 | — |
| −2 | K072151 | P.004 RC Cares Titanium and Ceramic Abutments | Straumann USA | 2007 | 1 |
| −1 | K081005 | P.004 NC Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | 1 |
| 0 (this device) | K150899 | Straumann CARES Titanium Alloy (TAN) Abutment | Straumann USA, LLC | 2015 | — |
| +1 | K162890 | BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing… | Straumann USA, LLC | 2017 | — |
| +1 | K171649 | Straumann CARES M-Series CAD/CAM System | Institut Straumann AG | 2018 | — |
| +2 | K231395 | INNO SLA Submerged Narrow Implant System | Cowellmedi Co., Ltd. | 2023 | — |
| +2 | K192893 | Straumann Ceramic Healing Abutments | Institut Straumann AG | 2020 | — |
| +3 | K251605 | DIMPLO Implant System | DIMPLO, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 3 | 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 30.6 · 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? (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 | Decided |
|---|---|---|---|
| * | K061277 | Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic CopingSummary page 4…sseous dental implant abutment (21 CFR 872.3630) Proprietary Name: Straumann® CARES® Titanium Alloy (TAN) Abutments Primary Predicate K061277 – Straumann RN CARES Ceramic Coping Device: Reference Predicate K072151 – P.004 RC CARES Titanium and… | 2007 |
| * | K072151 | P.004 RC Cares Titanium and Ceramic AbutmentsSummary page 4…ES® Titanium Alloy (TAN) Abutments Primary Predicate K061277 – Straumann RN CARES Ceramic Coping Device: Reference Predicate K072151 – P.004 RC CARES Titanium and Ceramic Abutment Device(s): K081005 – P.004 NC CARES Titanium and Ceramic A… | 2007 |
| * | K081005 | P.004 NC Cares Titanium and Ceramic AbutmentsSummary page 4…RN CARES Ceramic Coping Device: Reference Predicate K072151 – P.004 RC CARES Titanium and Ceramic Abutment Device(s): K081005 – P.004 NC CARES Titanium and Ceramic Abutment Reference Device(s): K052272 – Straumann RN CARES Titanium Abutment… | 2008 |
| † | K052272 | Straumann Computer Aided Restoration Service | 2006 |
| † | K082764 | Straumann WN Cares Titanium Abutment | 2008 |
What descends from it? (11)
See all 113 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 25 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 15 ancestors have a recall of any class.
- Of its descendants, K162890 (Straumann USA, LLC, 2017) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K061277.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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?
The Straumann CARES® TAN abutments are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/ screw-retained.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150899 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150899: Straumann CARES Titanium Alloy (TAN) Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150899
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