FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT
K Number: K022025
·
Decision Aug 15, 2002
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
76
Applicant Total
7
Review Days
56
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Basic Information
- Device Name
- MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT
- K Number
- K022025
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3250
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Milton Hodosh, M.D.
- Date Received
- June 20, 2002
- Decision Date
- August 15, 2002
- Product Code
- EJK
- 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 |
|---|---|---|---|
| EJK | Liner, Cavity, Calcium Hydroxide | 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 |
| 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 |
| K882417 | POTASSIUM NITRATE POLYCARBOXYLATE DENTAL CEMENT | Feb 13, 1989 | Substantially Equivalent |