PROCEARA COPINGS AND PONTIC
FDA 510(k) clearance K032562 · decided 2004-02-06
Clearance details
- K-number
- K032562
- Device name
- PROCEARA COPINGS AND PONTIC
- Applicant
- Nobel Biocare AB
- Decision
- Substantially Equivalent
- Date received
- 2003-08-20
- Decision date
- 2004-02-06
- Days to decision
- 170 days
- Clearance type
- Traditional
- Product code
- ELL
- Device class
- 2
- Regulation number
- 872.3920
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Yorba Linda, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.