CEREC Ortho Software
FDA 510(k) clearance K171122 · decided 2018-01-11
Clearance details
- K-number
- K171122
- Device name
- CEREC Ortho Software
- Applicant
- Dentsply Sirona
- Decision
- Substantially Equivalent
- Date received
- 2017-04-17
- Decision date
- 2018-01-11
- Days to decision
- 269 days
- Clearance type
- Traditional
- Product code
- PNN
- Device class
- 2
- Regulation number
- 872.5470
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- York, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.