PROCERA PREPARABLE ABUTMENT SYSTEM
FDA 510(k) clearance K974150 · decided 1998-01-23
Clearance details
- K-number
- K974150
- Device name
- PROCERA PREPARABLE ABUTMENT SYSTEM
- Applicant
- Nobel Biocare Uas, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-11-04
- Decision date
- 1998-01-23
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- NHA
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Westmont, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.