PULPDENT FLUORIDE VARNISH
FDA 510(k) clearance K093620 · decided 2010-03-10
Clearance details
- K-number
- K093620
- Device name
- PULPDENT FLUORIDE VARNISH
- Applicant
- Pulpdent Corporation
- Decision
- Substantially Equivalent
- Date received
- 2009-11-23
- Decision date
- 2010-03-10
- Days to decision
- 107 days
- Clearance type
- Traditional
- Product code
- LBH
- Device class
- 2
- Regulation number
- 872.3260
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Watertown, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.