CARIESCAN PRO
FDA 510(k) clearance K090598 · decided 2009-12-15
Clearance details
- K-number
- K090598
- Device name
- CARIESCAN PRO
- Applicant
- Cariescan , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2009-03-05
- Decision date
- 2009-12-15
- Days to decision
- 285 days
- Clearance type
- Traditional
- Product code
- NBL
- Device class
- 2
- Regulation number
- 872.1745
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Dundee, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.