FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502
K Number: K051750
·
Decision Sep 19, 2005
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
137
Applicant Total
103
Review Days
82
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Basic Information
- Device Name
- FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502
- K Number
- K051750
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3260
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ultradent Products, Inc.
- Date Received
- June 29, 2005
- Decision Date
- September 19, 2005
- 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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