FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDIX RADICULAR BIOCERAMIC PIN
K Number: K834363
·
Decision Feb 27, 1984
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
5
Applicant Total
4
Review Days
123
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Basic Information
- Device Name
- ENDIX RADICULAR BIOCERAMIC PIN
- K Number
- K834363
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3890
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- C.B.S. Biotechnics, Inc.
- Date Received
- October 27, 1983
- Decision Date
- February 27, 1984
- Product Code
- ELS
- 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 |
|---|---|---|---|
| ELS | Splint, Endodontic Stabilizing | FDA class 2 | Dental |
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