510(k) · Cleared
ClearedCARES Screw - Retained Bars and Bridges (SRBB)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medentika GmbH · NHA Abutment, Implant, Dental, Endosseous
Cleared on Dec 8, 2020 as substantially equivalent to K190097 (Institut Straumann AG, 2019) after a 168-day review. Its family tree reaches back 2 generations to 2014.
- Decided
- Dec 8, 2020
- Review
- 168 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K132844 (2014). No later device cites it as a predicate yet.
- Root · 2 generations backK132844 Straumann Cares Bone Level Screw Retained Bars, Straumann Cares Bone…Straumann USA, LLC · 2014
- 1 generation backK190097 Straumann CARES Screw-Retained Bridges and BarsInstitut Straumann AG · 2019
- This deviceK201711 CARES Screw - Retained Bars and Bridges (SRBB)Medentika GmbH · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K201711 | CARES Screw - Retained Bars and Bridges (SRBB) | Medentika GmbH | 2020 | — |
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 |
|---|---|---|---|
| * | K190097 | Straumann CARES Screw-Retained Bridges and BarsSummary page 5…CARES® Screw - Retained Bars and Bridges (SRBB) 510(k) Summary 5.3 Predicate Device(s) Primary Predicate: K190097 – Straumann CARES® Screw-Retained Bridges and Bars Reference Devices: K170838 – Medentika CAD/CAM TiBases … | 2019 |
| † | K170838 | Medentika CAD/CAM TiBases | 2017 |
| † | K180536 | Neodent Implant System – GM Line | 2018 |
| † | K120414 | Osseospeed Plus | 2012 |
| † | K180564 | Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases | 2019 |
| † | K150203 | Medentika CAD/CAM Abutments | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 6 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
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. CARES® Screw-retained Bridges and Bars are indicated for screw-retained restorations. CARES® Screw - Retained Bars and Bridges are designed to interface with the following dental implant…
Read the full statement (268 words)
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. CARES® Screw-retained Bridges and Bars are indicated for screw-retained restorations.
CARES® Screw - Retained Bars and Bridges are designed to interface with the following dental implant systems (Implant System Compatibility / Series / Implant diameter (mm) / Platform diameter (mm)):
Nobel Biocare Replace Select / E-Series / Diameters 3.5, 4.3, 5.0, 6.0 / Platform 3.5, 4.3, 5.0, 6.0
Dentsply Implants - ASTRA TECH OsseoSpeed EV / EV-Series / 3.0, 3.6, 4.2, 4.8, 5.4 / Platform 3.0, 3.6, 4.2, 4.8, 5.4
Nobel Biocare NobelActive / F-Series / Diameter 3.0, 3.5, 4.3, 5.0 / Platform 3.0, 3.5, 3.9 (4.3), 3.9 (5.0)
Neodent - Grand Morse / GM Series / Diameters 3.5, 3.75, 4.0, 4.3, 5.0, 6.0 / Platform 3.0
Biomet 3i - Certain / H-Series / Diameter 3.25, 4.0, 5.0 / Platform 3.4, 4.1, 5.0
Biomet 3i – External Hex / I-Series / Diameter 3.25, 3.75, 4.0, 5.0 / Platform 3.4, 4.1, 5.0
Nobel Biocare - Brånemark System / K-Series / Diameter 3.3, 3.75, 4.0, 5.0 / Platform 3.5, 4.1, 4.1, 5.1
Zimmer Dental Tapered Screw-vent / R-Series / Diameter 3.3, 3.7, 4.1, 4.7, 6.0 / Platform 3.5, 4.5, 5.7
Dentsply Implants - ASTRA TECH OsseoSpeed TX / S-Series / Diameter 3.5, 4.0, 4.5, 5.0 / Platform 3.5, 4.0, 4.5, 5.0
Dentsply Implants – XiVE S / T- Series / Diameter 3.4, 3.8, 4.5, 5.5 / Platform 3.4, 3.8, 4.5, 5.5
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201711 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201711: CARES Screw - Retained Bars and Bridges (SRBB).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201711
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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