IP TEMP CEMENT
FDA 510(k) clearance K111685 · decided 2011-09-02
Clearance details
- K-number
- K111685
- Device name
- IP TEMP CEMENT
- Applicant
- Shofu Dental Corporation
- Decision
- Substantially Equivalent
- Date received
- 2011-06-16
- Decision date
- 2011-09-02
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- EMA
- Device class
- 2
- Regulation number
- 872.3275
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- San Marcos, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.