FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POTASSIUM NITRATE COMPOSITE RESTORATION PIT AND
K Number: K905582
·
Decision Apr 29, 1991
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
130
Applicant Total
7
Review Days
138
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- POTASSIUM NITRATE COMPOSITE RESTORATION PIT AND
- K Number
- K905582
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3765
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Milton Hodosh, M.D.
- Date Received
- December 12, 1990
- Decision Date
- April 29, 1991
- Product Code
- EBC
- 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 |
|---|---|---|---|
| EBC | Sealant, Pit And Fissure, And Conditioner | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EBC), ordered by most recent decision date.
Any-Com Seal
FDA 510(k)
FDA Class 2
·Dental
Parkell Pit and Fissure Sealant
FDA 510(k)
FDA Class 2
·Dental
UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio
FDA 510(k)
FDA Class 2
·Dental
Enamel Coating Resin
FDA 510(k)
FDA Class 2
·Dental
BA Pit & Fissure Sealant
FDA 510(k)
FDA Class 2
·Dental
Helioseal F Plus
FDA 510(k)
FDA Class 2
·Dental
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 |
| K895988 | POTASSIUM NITRATE-ZINC OXIDE EUGENOL TEMP. DENTAL | Mar 7, 1990 | Substantially Equivalent |
| K882417 | POTASSIUM NITRATE POLYCARBOXYLATE DENTAL CEMENT | Feb 13, 1989 | Substantially Equivalent |