MULTIPLE (TOOTH DESENSITIZER)
FDA 510(k) clearance K052263 · decided 2005-12-16
Clearance details
- K-number
- K052263
- Device name
- MULTIPLE (TOOTH DESENSITIZER)
- Applicant
- Cosmedent, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-08-19
- Decision date
- 2005-12-16
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- LBH
- Device class
- 2
- Regulation number
- 872.3260
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Chicago, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.