FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
SUPER-DENT ALGINATE,NORMAL SET, FAST SET,SUPER DELUXE DUSTLESS ALGINATE, NORMAL SET, DELUXE DUTLESS ALGINATE, FAST SET
K Number: K965083
·
Decision Apr 4, 1997
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
401
Applicant Total
3
Review Days
106
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Basic Information
- Device Name
- SUPER-DENT ALGINATE,NORMAL SET, FAST SET,SUPER DELUXE DUSTLESS ALGINATE, NORMAL SET, DELUXE DUTLESS ALGINATE, FAST SET
- K Number
- K965083
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- S.S. White Mfg., Ltd.
- Date Received
- December 19, 1996
- Decision Date
- April 4, 1997
- Product Code
- ELW
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ELW | Material, Impression | FDA class 2 | Dental |
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