TOMAS PIN
FDA 510(k) clearance K042965 · decided 2005-04-15
Clearance details
- K-number
- K042965
- Device name
- TOMAS PIN
- Applicant
- Dentaurum, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-10-27
- Decision date
- 2005-04-15
- Days to decision
- 170 days
- Clearance type
- Traditional
- Product code
- OAT
- Device class
- 2
- Regulation number
- 872.3640
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Newtown, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.