FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EASY PNEUMATIC CROWN AND BRIDGE REMOVER
K Number: K951299
·
Decision Aug 29, 1995
Classifications
1
FEI Numbers
122
Registration Numbers
122
Same Product Code
18
Applicant Total
1
Review Days
160
Basic Information
- Device Name
- EASY PNEUMATIC CROWN AND BRIDGE REMOVER
- K Number
- K951299
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- DENTCO, INC.
- Date Received
- March 22, 1995
- Decision Date
- August 29, 1995
- Product Code
- EIS
- 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 |
|---|---|---|---|
| EIS | Remover, Crown | FDA class 1 | Dental |
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