DINABASE (TM)
FDA 510(k) clearance K971138 · decided 1997-07-21
Clearance details
- K-number
- K971138
- Device name
- DINABASE (TM)
- Applicant
- Sultan Chemists, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-03-28
- Decision date
- 1997-07-21
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- EBI
- Device class
- 2
- Regulation number
- 872.3760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Englewood, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.