INTERGRO ORAL
FDA 510(k) clearance K070147 · decided 2007-05-14
Clearance details
- K-number
- K070147
- Device name
- INTERGRO ORAL
- Applicant
- Biomet 3i
- Decision
- Substantially Equivalent
- Date received
- 2007-01-16
- Decision date
- 2007-05-14
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- NUN
- Device class
- 2
- Regulation number
- 872.3930
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Palm Beach Gardens, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.