FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POTASSIUM NITRATE POLYCARBOXYLATE DENTAL CEMENT
K Number: K882417
·
Decision Feb 13, 1989
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
504
Applicant Total
7
Review Days
245
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Basic Information
- Device Name
- POTASSIUM NITRATE POLYCARBOXYLATE DENTAL CEMENT
- K Number
- K882417
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Milton Hodosh, M.D.
- Date Received
- June 13, 1988
- Decision Date
- February 13, 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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Other Clearances by Milton Hodosh, M.D.
| K Number | Device Name | ||
|---|---|---|---|
| K032175 | DESENS-IONOMER | Oct 9, 2003 | Substantially Equivalent |
| K031721 | COMPOSITE RESTORATION MATERIAL | Sep 11, 2003 | Substantially Equivalent |
| K022025 | MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT | Aug 15, 2002 | Substantially Equivalent |
| K925207 | GLASS IONOMER CEMENT | Jul 8, 1993 | Substantially Equivalent |
| K905582 | POTASSIUM NITRATE COMPOSITE RESTORATION PIT AND | Apr 29, 1991 | Substantially Equivalent |
| K895988 | POTASSIUM NITRATE-ZINC OXIDE EUGENOL TEMP. DENTAL | Mar 7, 1990 | Substantially Equivalent |