510(k) · Cleared
ClearedStraumann Cares Bridge; Straumann Cares Dolder Bar
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 Dec 13, 2010 as substantially equivalent to K090069 (Nobel Biocare AB, 2009) and 2 other predicates after a 201-day review. Its family tree reaches back 11 generations to 1990. 167 later devices descend from it.
- Decided
- Dec 13, 2010
- Review
- 201 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K894844 (1990). 76 ancestors in all, the oldest K871863 (1987). 167 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 7 generations between
- 3 generations backK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- 2 generations backK082545 Straumann NN Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008
- 1 generation backK093113 Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG · 2009
- This deviceK101465 Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010
- Descendant · cites it directly · 165 of its ownK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- Descendant · 2 generations on · 129 of its ownK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
- Descendant · 2 generations on · 89 of its ownK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- Descendant · 3 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- Descendant · 4 generations on · 51 of its ownK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
Show all 11 generations
- Root · 11 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 10 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 9 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 8 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 7 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 6 generations backK052272 Straumann Computer Aided Restoration ServiceStraumann USA · 2006
- 5 generations backK061277 Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic…Straumann USA · 2007
- 4 generations backK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
- 3 generations backK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- 2 generations backK082545 Straumann NN Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008
- 1 generation backK093113 Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG · 2009
- This deviceK101465 Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010
Showing 5 of 167 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 167 · See all- K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG · 2012 · cites it directly165descendants
- K150203Medentika CAD/CAM AbutmentsMedentika GmbH · 2015 · 2 generations on129descendants
- K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015 · 2 generations on89descendants
- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 3 generations on86descendants
- K173908DESS Dental Smart SolutionsTerrats Medical SL · 2018 · 4 generations on51descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −10 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −9 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −8 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −7 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −6 | K052272 | Straumann Computer Aided Restoration Service | Straumann USA | 2006 | — |
| −5 | K061277 | Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping | Straumann USA | 2007 | — |
| −4 | K072151 | P.004 RC Cares Titanium and Ceramic Abutments | Straumann USA | 2007 | 1 |
| −3 | K081005 | P.004 NC Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | 1 |
| −2 | 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 | — |
| 0 (this device) | K101465 | Straumann Cares Bridge; Straumann Cares Dolder Bar | Institut Straumann AG | 2010 | — |
| +1 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
| +2 | K150203 | Medentika CAD/CAM Abutments | Medentika GmbH | 2015 | — |
| +2 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| +3 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| +4 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 9 | 0 |
| 1994 | 9 | 0 |
| 1995 | 7 | 0 |
| 1996 | 8 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 7 | 0 |
| 2016 | 5 | 0 |
| 2017 | 7 | 0 |
| 2018 | 10 | 0 |
| 2019 | 7 | 0 |
| 2020 | 12 | 0 |
| 2021 | 17 | 0 |
| 2022 | 14 | 0 |
| 2023 | 24 | 0 |
| 2024 | 24 | 0 |
| 2025 | 25 | 0 |
| 2026 | 11 | 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 |
|---|---|---|---|
| * | K090069 | Procera Implant Bridge OverdentureSummary page 2…A 37 Predicate Devices Procera Implant Bridge Overdlenture .......... K090069 Procera Implant Bridge......................... K041236 ETKON ESi, MODEL 019.0001, ETKON VISUAL, K093 113 STRAUMANN C… | 2009 |
| * | K041236 | Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Summary page 2…37 Predicate Devices Procera Implant Bridge Overdlenture .......... K090069 Procera Implant Bridge......................... K041236 ETKON ESi, MODEL 019.0001, ETKON VISUAL, K093 113 STRAUMANN CADCAM ABUTMENT Device Description Straumann® CARES® S… | 2004 |
| * | K093113 | Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentSummary page 2…ces Procera Implant Bridge Overdlenture .......... K090069 Procera Implant Bridge......................... K041236 ETKON ESi, MODEL 019.0001, ETKON VISUAL, K093 113 STRAUMANN CADCAM ABUTMENT Device Description Straumann® CARES® Screw-Retained Bridges and Straumann® CARES® Dolder® Bars are d… | 2009 |
What descends from it? (167)
See all 1672 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 20 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 11 of the 76 ancestors have a recall of any class.
- Of its descendants, K120822 (Institut Straumann AG, 2012) has gone furthest, with 165 descendants of its own.
- 7 other devices also cite its predicate K090069.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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® Screw-retained Bridge and Straumann® CARES® Dolder® Bar are indicated for use as bars and bridges that attach to dental implants (Straumann RN (Regular Neck) 04.8mm and WN (Wide Neck) 06.5mm) in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.
The Straumann® CARES® Screw-retained Bridge is available in different sizes and spans and can be fitted on 2 to 16 implants.
The Straumann® CARES® Dolder® Bar is available in different sizes and spans and can be fitted on 2 to 10 implant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101465 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101465: Straumann Cares Bridge; Straumann Cares Dolder Bar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101465
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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