Sirona Dental CAD/CAM System with InLab Software
FDA 510(k) clearance K200191 · decided 2020-08-19
Clearance details
- K-number
- K200191
- Device name
- Sirona Dental CAD/CAM System with InLab Software
- Applicant
- Dentsply Sirona
- Decision
- Substantially Equivalent
- Date received
- 2020-01-27
- Decision date
- 2020-08-19
- Days to decision
- 205 days
- Clearance type
- Traditional
- Product code
- PNP
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- York, PA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| Straumann CARES Visual and Nova Dental CAD (K233252) | Institut Straumann AG | 2024-12-26 |
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Recalls involving this device
No recalls on record reference this clearance.