FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KERR COMMAND ULTRAFINE POLISHING PASTE
K Number: K843022
·
Decision Aug 24, 1984
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
76
Applicant Total
32
Review Days
23
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Basic Information
- Device Name
- KERR COMMAND ULTRAFINE POLISHING PASTE
- K Number
- K843022
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6030
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Kerr Corporation (Danbury)
- Date Received
- August 1, 1984
- Decision Date
- August 24, 1984
- Product Code
- EJR
- 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 |
|---|---|---|---|
| EJR | Agent, Polishing, Abrasive, Oral Cavity | FDA class 1 | Dental |
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| K934690 | KERR OPTIBOND, MODIFICATION | Dec 30, 1993 | Substantially Equivalent |
| K923546 | OPTIBOND | Sep 29, 1992 | Substantially Equivalent |
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