Straumann CARES M-Series CAD/CAM System
FDA 510(k) clearance K203456 · decided 2021-06-23
Clearance details
- K-number
- K203456
- Device name
- Straumann CARES M-Series CAD/CAM System
- Applicant
- Institut Straumann AG
- Decision
- Substantially Equivalent
- Date received
- 2020-11-23
- Decision date
- 2021-06-23
- Days to decision
- 212 days
- Clearance type
- Special
- Product code
- NHA
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Basel, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.