FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
ENDOSOLV E
K Number: K780003
·
Decision Jan 20, 1978
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
40
Applicant Total
11
Review Days
22
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Basic Information
- Device Name
- ENDOSOLV E
- K Number
- K780003
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Septodont, Inc.
- Date Received
- December 29, 1977
- Decision Date
- January 20, 1978
- Product Code
- KJJ
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| KJJ | Cleanser, Root Canal | FDA unclassified | Unknown |
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Other Clearances by Septodont, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K771114 | NEUTROCIM | Jan 4, 1978 | Substantially Equivalent |
| K761355 | SELFAST | Jan 3, 1977 | 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 |