510(k) · Cleared
ClearedStraumann CARES Screw-Retained Bridges and Bars
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 Jun 26, 2019 as substantially equivalent to K132844 (Straumann USA, LLC, 2014) after a 155-day review. Its family tree reaches back 1 generation to 2014. 1 later device descends from it.
- Decided
- Jun 26, 2019
- Review
- 155 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K132844 (2014). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK132844 Straumann Cares Bone Level Screw Retained Bars, Straumann Cares Bone…Straumann USA, LLC · 2014
- This deviceK190097 Straumann CARES Screw-Retained Bridges and BarsInstitut Straumann AG · 2019
- Descendant · cites it directly · 0 of its ownK201711 CARES Screw - Retained Bars and Bridges (SRBB)Medentika GmbH · 2020
Most influential descendants
Showing 1 of 1 · See all- K201711CARES Screw - Retained Bars and Bridges (SRBB)Medentika GmbH · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K132844 | Straumann Cares Bone Level Screw Retained Bars, Straumann Cares Bone Level… | Straumann USA, LLC | 2014 | — |
| 0 (this device) | K190097 | Straumann CARES Screw-Retained Bridges and Bars | Institut Straumann AG | 2019 | — |
| +1 | K201711 | CARES Screw - Retained Bars and Bridges (SRBB) | Medentika GmbH | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (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 |
|---|---|---|---|
| * | K132844 | Straumann Cares Bone Level Screw Retained Bars, Straumann Cares Bone Level Screw…Summary page 4…Regulation Number: 21 CFR 872.3630 Regulatory Class: II Product Code: NHA Classification Panel: Dental Devices 5.3 Predicate Device Primary Predicate: K132844 – Straumann CARES Bone Level Screw-Retained Bars, Straumann CARES Bone Level Screw-Retained Bridges Referenc… | 2014 |
| † | K173961 | Straumann BLX Implant System | 2018 |
| † | K150203 | Medentika CAD/CAM Abutments | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201711 | CARES Screw - Retained Bars and Bridges (SRBB) | 2020 | 0 |
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?
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Straumann® CARES® Screw-retained Bridges and Bars are indicated for use as bars and bridges that attach to implants to provide support for prosthetic reconstructions such as bridges and overdentures. The final processed products have the purpose of restoring chewing function. Straumann® CARES® Screw-retained Bridges and Bars are indicated for screw-retained restorations. Straumann® CARES® Screw-retained Bridges and Bars are designed to interface with the Bone Level (BL), Tissue Level (TL), and BLX implants of the Straumann Dental Implant System (SDIS).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190097 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190097: Straumann CARES Screw-Retained Bridges and Bars.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190097
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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