ENIGMA HI-BASE DENTURE BASE MATERIAL
FDA 510(k) clearance K993717 · decided 1999-12-22
Clearance details
- K-number
- K993717
- Device name
- ENIGMA HI-BASE DENTURE BASE MATERIAL
- Applicant
- Davis Schottlander & Davis, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1999-11-03
- Decision date
- 1999-12-22
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- EBI
- Device class
- 2
- Regulation number
- 872.3760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Tonawanda, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.