FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WILEY/ESPOSITO DENTAL GUARD
K Number: K935713
·
Decision Jan 5, 1994
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
2
Applicant Total
4
Review Days
36
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Basic Information
- Device Name
- WILEY/ESPOSITO DENTAL GUARD
- K Number
- K935713
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5820
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Fvtnks
- Date Received
- November 30, 1993
- Decision Date
- January 5, 1994
- Product Code
- BRW
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BRW | Protector, Dental | FDA class 1 | Anesthesiology |
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