SUPER-DENT ALGINATE,NORMAL SET, FAST SET,SUPER DELUXE DUSTLESS ALGINATE, NORMAL SET, DELUXE DUTLESS ALGINATE, FAST SET
FDA 510(k) clearance K965083 · decided 1997-04-04
Clearance details
- K-number
- K965083
- Device name
- SUPER-DENT ALGINATE,NORMAL SET, FAST SET,SUPER DELUXE DUSTLESS ALGINATE, NORMAL SET, DELUXE DUTLESS ALGINATE, FAST SET
- Applicant
- S.S. White Mfg., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1996-12-19
- Decision date
- 1997-04-04
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- ELW
- Device class
- 2
- Regulation number
- 872.3660
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Gloucester, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.