ScanX Intraoral View
FDA 510(k) clearance K170733 · decided 2017-05-01
Clearance details
- K-number
- K170733
- Device name
- ScanX Intraoral View
- Applicant
- Duerr Dental AG
- Decision
- Substantially Equivalent
- Date received
- 2017-03-10
- Decision date
- 2017-05-01
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- MUH
- Device class
- 2
- Regulation number
- 872.1800
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Bietigheim-Bissingen, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.