FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247
K Number: K090519
·
Decision Apr 15, 2009
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
137
Applicant Total
331
Review Days
48
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Basic Information
- Device Name
- VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247
- K Number
- K090519
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.3260
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3M Company
- Date Received
- February 26, 2009
- Decision Date
- April 15, 2009
- Product Code
- LBH
- 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 |
|---|---|---|---|
| LBH | Varnish, Cavity | FDA class 2 | Dental |
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