510(k) · Cleared
ClearedStraumann CARES M-Series CAD/CAM System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Institut Straumann AG · NHA Abutment, Implant, Dental, Endosseous
Cleared on Feb 22, 2018 as substantially equivalent to K111421 (Sirona Dental Systems GmbH, 2012) and 3 other predicates after a 262-day review. Its family tree reaches back 15 generations to 1990. 3 later devices descend from it.
- Decided
- Feb 22, 2018
- Review
- 262 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 15 generations to K894844 (1990). 189 ancestors in all, the oldest K871863 (1987). 3 later devices descend from it, 3 citing it directly.
- Root · 15 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 11 generations between
- 3 generations backK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- 2 generations backK132219 Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase…Straumann USA, LLC · 2014
- 1 generation backK142890 Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN…Straumann USA, LLC · 2015
- This deviceK171649 Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG · 2018
- Descendant · cites it directly · 0 of its ownK243478 Straumann InLab Validated WorkflowInstitut Straumann AG · 2025
- Descendant · cites it directly · 0 of its ownK203750 Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG · 2021
- Descendant · cites it directly · 0 of its ownK203456 Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG · 2021
Show all 15 generations
- Root · 15 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 14 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 13 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 12 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 11 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 10 generations backK052272 Straumann Computer Aided Restoration ServiceStraumann USA · 2006
- 9 generations backK061277 Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic…Straumann USA · 2007
- 8 generations backK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
- 7 generations backK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- 6 generations backK082545 Straumann NN Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008
- 5 generations backK093113 Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG · 2009
- 4 generations backK101465 Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010
- 3 generations backK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- 2 generations backK132219 Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase…Straumann USA, LLC · 2014
- 1 generation backK142890 Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN…Straumann USA, LLC · 2015
- This deviceK171649 Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG · 2018
Most influential descendants
Showing 3 of 3 · See all- K243478Straumann InLab Validated WorkflowInstitut Straumann AG · 2025 · cites it directly0descendants
- K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG · 2021 · cites it directly0descendants
- K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −14 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −13 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −12 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −11 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −10 | K052272 | Straumann Computer Aided Restoration Service | Straumann USA | 2006 | — |
| −9 | K061277 | Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping | Straumann USA | 2007 | — |
| −8 | K072151 | P.004 RC Cares Titanium and Ceramic Abutments | Straumann USA | 2007 | 1 |
| −7 | K081005 | P.004 NC Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | 1 |
| −6 | K082545 | Straumann NN Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | — |
| −5 | K093113 | Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam Abutment | Institut Straumann AG | 2009 | — |
| −4 | K101465 | Straumann Cares Bridge; Straumann Cares Dolder Bar | Institut Straumann AG | 2010 | — |
| −3 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
| −2 | K132219 | Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM)… | Straumann USA, LLC | 2014 | — |
| −1 | K142890 | Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann… | Straumann USA, LLC | 2015 | — |
| 0 (this device) | K171649 | Straumann CARES M-Series CAD/CAM System | Institut Straumann AG | 2018 | — |
| +1 | K243478 | Straumann InLab Validated Workflow | Institut Straumann AG | 2025 | — |
| +1 | K203750 | Straumann CARES P-Series CAD/CAM System | Institut Straumann AG | 2021 | — |
| +1 | K203456 | Straumann CARES M-Series CAD/CAM System | Institut Straumann AG | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 12 | 0 |
| 1994 | 11 | 0 |
| 1995 | 9 | 0 |
| 1996 | 14 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 7 | 0 |
| 2000 | 7 | 0 |
| 2001 | 9 | 0 |
| 2002 | 12 | 0 |
| 2003 | 8 | 0 |
| 2004 | 9 | 0 |
| 2005 | 8 | 0 |
| 2006 | 13 | 0 |
| 2007 | 13 | 0 |
| 2008 | 9 | 0 |
| 2009 | 5 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2025 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K111421 | Sirona Dental Cad/Cam SystemSummary page 4…ation Name: Endosseous dental abutment (21 CFR 872.3630) Proprietary Name: Straumann® CARES M-Series CAD/CAM System Predicate Device(s): • K111421 SIRONA DENTAL CAD/CAM SYSTEM Reference Device(s): • K120822 Straumann CARES Variobase Abutment… | 2012 |
| * | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Summary page 4…etary Name: Straumann® CARES M-Series CAD/CAM System Predicate Device(s): • K111421 SIRONA DENTAL CAD/CAM SYSTEM Reference Device(s): • K120822 Straumann CARES Variobase Abutment • K133421 Magellan Screw-Retained Abutments… | 2012 |
| * | K142890 | Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Summary page 4…• K151157 Variobase for Bridge/Bars • K150899 Straumann CARES TAN Abutments • K142890 Straumann Variobase Abutment • K170354 Straumann Variobase Abutments… | 2015 |
| * | K150899 | Straumann CARES Titanium Alloy (TAN) AbutmentSummary page 4…OLID fx • K063511 Ceramill ZI • K151157 Variobase for Bridge/Bars • K150899 Straumann CARES TAN Abutments • K142890 Straumann Variobase Abutment… | 2015 |
| † | K133421 | Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal Screw | 2014 |
| † | K152383 | Ceramill Zolid FX | 2015 |
| † | K063511 | Ceramill ZI | 2007 |
| † | K151157 | NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for… | 2015 |
| † | K170354 | Straumann Variobase Abutments | 2017 |
| † | K150203 | Medentika CAD/CAM Abutments | 2015 |
What descends from it? (3)
3 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 28 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 20 of the 189 ancestors have a recall of any class.
- Of its descendants, K243478 (Institut Straumann AG, 2025) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K111421.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 M-Series CAD/CAM System is indicated for the design and fabrication of single or multiple-unit implant-borne prosthetics for the restoration of partially or fully edentulous mandibles and maxillae. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners or Extra-Oral Scanners, CAD software, CAM software, restoration material blanks, milling machines and associated tooling and…
Read the full statement (107 words)
The Straumann CARES M-Series CAD/CAM System is indicated for the design and fabrication of single or multiple-unit implant-borne prosthetics for the restoration of partially or fully edentulous mandibles and maxillae. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners or Extra-Oral Scanners, CAD software, CAM software, restoration material blanks, milling machines and associated tooling and accessories. The system is used to design and fabricate CAD/CAM milled coping, crown and bridge restorations to be cemented onto Straumann® Variobase® Abutments, as well as milled abutments to be affixed to the endosseous dental implants of the Straumann® Dental Implant System using a basal screw.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171649 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171649: Straumann CARES M-Series CAD/CAM System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171649
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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