FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TEFGEN-FD
K Number: K935137
·
Decision Aug 15, 1994
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
30
Applicant Total
5
Review Days
291
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Basic Information
- Device Name
- TEFGEN-FD
- K Number
- K935137
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- American Custom Medical, Inc.
- Date Received
- October 28, 1993
- Decision Date
- August 15, 1994
- Product Code
- NPK
- 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 |
|---|---|---|---|
| NPK | Barrier, Synthetic, Intraoral | FDA class 2 | Dental |
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