ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH
FDA 510(k) clearance K080228 · decided 2008-03-27
Clearance details
- K-number
- K080228
- Device name
- ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH
- Applicant
- Novamin Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-01-30
- Decision date
- 2008-03-27
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- LBH
- Device class
- 2
- Regulation number
- 872.3260
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Alachua, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.