FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DENTAL IMPLANT, CARBON COATED METAL
K Number: K772304
·
Decision Jan 3, 1978
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
2
Review Days
19
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Basic Information
- Device Name
- DENTAL IMPLANT, CARBON COATED METAL
- K Number
- K772304
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- General Atomic Co.
- Date Received
- December 15, 1977
- Decision Date
- January 3, 1978
- Product Code
- DZE
- 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 |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | FDA class 2 | Dental |
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Other Clearances by General Atomic Co.
| K Number | Device Name | ||
|---|---|---|---|
| K770440 | IMPLANT, DENTAL, PYROLITE CARBON ENDO. | Mar 15, 1977 | Substantially Equivalent |