PULPDENT TOUCHDOWN
FDA 510(k) clearance K953217 · decided 1995-08-25
Clearance details
- K-number
- K953217
- Device name
- PULPDENT TOUCHDOWN
- Applicant
- Pulpdent Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-07-10
- Decision date
- 1995-08-25
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- DYH
- Device class
- 2
- Regulation number
- 872.3750
- 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.