FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SELFAST
K Number: K761355
·
Decision Jan 3, 1977
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
504
Applicant Total
11
Review Days
5
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Basic Information
- Device Name
- SELFAST
- K Number
- K761355
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Septodont, Inc.
- Date Received
- December 29, 1976
- Decision Date
- January 3, 1977
- Product Code
- EMA
- 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 |
|---|---|---|---|
| EMA | Cement, Dental | FDA class 2 | Dental |
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Other Clearances by Septodont, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K780003 | ENDOSOLV E | Jan 20, 1978 | Substantially Equivalent |
| K771114 | NEUTROCIM | Jan 4, 1978 | Substantially Equivalent |
| K761354 | CIMPAT (PINK AND WHITE) | Jan 3, 1977 | Substantially Equivalent |
| K760798 | FLUOCAL GEL MINT | Nov 24, 1976 | Substantially Equivalent |
| K760799 | FLUOCAL GEL ORANGE | Nov 24, 1976 | Substantially Equivalent |
| K761024 | RACESTYPTINE RINGS | Nov 19, 1976 | Substantially Equivalent |
| K760658 | DETARTRINE P | Sep 27, 1976 | Substantially Equivalent |
| K760659 | CALCIPULPE | Sep 27, 1976 | Substantially Equivalent |
| K760660 | HYDROL | Sep 27, 1976 | Substantially Equivalent |
| K760657 | RACESTYPTINE CORD | Sep 27, 1976 | Substantially Equivalent |