AMORPHOUS DIAMOND COATED DRILL
FDA 510(k) clearance K990846 · decided 1999-06-10
Clearance details
- K-number
- K990846
- Device name
- AMORPHOUS DIAMOND COATED DRILL
- Applicant
- Nobel Biocare Uas, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-03-15
- Decision date
- 1999-06-10
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- DZI
- Device class
- 2
- Regulation number
- 872.4120
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Yorba Linda, CA, US
- Third-party review
- No
- Expedited review
- No
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