FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CIMPAT S DENTAL CEMENT
K Number: K915467
·
Decision Feb 3, 1992
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
504
Applicant Total
21
Review Days
60
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Basic Information
- Device Name
- CIMPAT S DENTAL CEMENT
- K Number
- K915467
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Specialites Septodont
- Date Received
- December 5, 1991
- Decision Date
- February 3, 1992
- 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 Specialites Septodont
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|---|---|---|---|
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| K980633 | ENDOSOLV E | May 1, 1998 | Substantially Equivalent |
| K920692 | SEPTOCALCINE ULTRA | Apr 21, 1992 | Substantially Equivalent |
| K915466 | SEPTOPACK TEMPORARY FILLING | Feb 3, 1992 | Substantially Equivalent |
| K913573 | SAFETY PLUS DENTAL INJECTION NEEDLE | Nov 7, 1991 | Substantially Equivalent |
| K913572 | AUTOPACK NON-EUGENOL PERIODONTAL DRESSING | Oct 9, 1991 | Substantially Equivalent |
| K913574 | SEPTOCAL CAVITY LINER | Sep 30, 1991 | Substantially Equivalent |