FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TEMP BOND NE
K Number: K894219
·
Decision Sep 18, 1989
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
504
Applicant Total
32
Review Days
91
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Basic Information
- Device Name
- TEMP BOND NE
- K Number
- K894219
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Kerr Corporation (Danbury)
- Date Received
- June 19, 1989
- Decision Date
- September 18, 1989
- 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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| K951663 | TYTIN R | Jun 6, 1995 | Substantially Equivalent |
| K951511 | TYTIN ADMIX | May 2, 1995 | Substantially Equivalent |
| K942480 | M4 CONTRA-ANGLE HANDPIECE | Jan 27, 1995 | Substantially Equivalent |
| K940513 | OPTIBOND | Apr 15, 1994 | Substantially Equivalent |
| K935535 | TYTIN | Mar 11, 1994 | Substantially Equivalent |
| K934690 | KERR OPTIBOND, MODIFICATION | Dec 30, 1993 | Substantially Equivalent |
| K923546 | OPTIBOND | Sep 29, 1992 | Substantially Equivalent |
| K915847 | AUTOMIX DENTAL AMALGAMATOR | Mar 2, 1992 | Substantially Equivalent |