FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SAPPHIRE O/E ORAL EXAMINATION SYSTEM
K Number: K073483
·
Decision Apr 3, 2008
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
11
Applicant Total
8
Review Days
114
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Basic Information
- Device Name
- SAPPHIRE O/E ORAL EXAMINATION SYSTEM
- K Number
- K073483
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6350
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Den-Mat Holdings, LLC
- Date Received
- December 11, 2007
- Decision Date
- April 3, 2008
- Product Code
- NXV
- 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 |
|---|---|---|---|
| NXV | Diagnostic Light, Soft Tissue Detector | FDA class 2 | Dental |
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