510(k) · Cleared
ClearedStraumann Cares Bone Level Screw Retained Bars, Straumann Cares Bone Level Screw Retained Bridges
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 Jan 15, 2014 after a 126-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Jan 15, 2014
- Review
- 126 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK132844 Straumann Cares Bone Level Screw Retained Bars, Straumann Cares Bone…Straumann USA, LLC · 2014
- Descendant · cites it directly · 1 of its ownK190097 Straumann CARES Screw-Retained Bridges and BarsInstitut Straumann AG · 2019
- Descendant · 2 generations on · 0 of its ownK201711 CARES Screw - Retained Bars and Bridges (SRBB)Medentika GmbH · 2020
- Descendant · cites it directly · 0 of its ownK140737 Straumann Cares Screw Retained Bars/BridgeStraumann USA, LLC · 2014
Most influential descendants
Showing 3 of 3 · See all- K190097Straumann CARES Screw-Retained Bridges and BarsInstitut Straumann AG · 2019 · cites it directly1descendant
- K201711CARES Screw - Retained Bars and Bridges (SRBB)Medentika GmbH · 2020 · 2 generations on0descendants
- K140737Straumann Cares Screw Retained Bars/BridgeStraumann USA, LLC · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K132844 | Straumann Cares Bone Level Screw Retained Bars, Straumann Cares Bone Level… | Straumann USA, LLC | 2014 | — |
| +1 | K190097 | Straumann CARES Screw-Retained Bridges and Bars | Institut Straumann AG | 2019 | — |
| +2 | K201711 | CARES Screw - Retained Bars and Bridges (SRBB) | Medentika GmbH | 2020 | — |
| +1 | K140737 | Straumann Cares Screw Retained Bars/Bridge | Straumann USA, LLC | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
2 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?
- Of its descendants, K190097 (Institut Straumann AG, 2019) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 | — |
https://510kreport.com/device/K132844 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132844: Straumann Cares Bone Level Screw Retained Bars, Straumann Cares Bone Level Screw Retained Bridges.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132844
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026