P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS
FDA 510(k) clearance K072151 · decided 2007-09-11
Clearance details
- K-number
- K072151
- Device name
- P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS
- Applicant
- Straumann USA
- Decision
- Substantially Equivalent
- Date received
- 2007-08-03
- Decision date
- 2007-09-11
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- NHA
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620; recall (Z-1632-2026) | Straumann USA LLC | 2026-03-24 |