FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL SYRINGE TIPS
K Number: K964179
·
Decision Jan 9, 1997
Classifications
1
FEI Numbers
205
Registration Numbers
205
Same Product Code
913
Applicant Total
3
Review Days
83
Basic Information
- Device Name
- SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL SYRINGE TIPS
- K Number
- K964179
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- S.S. WHITE MFG., LTD.
- Date Received
- October 18, 1996
- Decision Date
- January 9, 1997
- Product Code
- EBF
- 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | FDA class 2 | Dental |
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