FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZENITH 40% PHOSPHORIC ACID GEL
K Number: K890464
·
Decision Feb 13, 1989
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
130
Applicant Total
14
Review Days
14
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Basic Information
- Device Name
- ZENITH 40% PHOSPHORIC ACID GEL
- K Number
- K890464
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3765
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Foremost Dental Mfg., Inc.
- Date Received
- January 30, 1989
- Decision Date
- February 13, 1989
- 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 |
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Other Clearances by Foremost Dental Mfg., Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K981813 | PERMACEM AUTOMIX LUTING CEMENT SYSTEM | Jul 10, 1998 | Substantially Equivalent |
| K980963 | HONIGUM AUTOMIX IMPRESSION MATERIAL (FOIL BAGS) AND HONIGUM QUICK IMPRESSION MATERIAL (CARTRIDGES) | May 11, 1998 | Substantially Equivalent |
| K970683 | ZENTIH FLOWABLE COMPOSITE (MULTIPLE) | Jul 15, 1997 | Substantially Equivalent |
| K970774 | TEMPOCEM NE (MULTIPLE) | Jun 3, 1997 | Substantially Equivalent |
| K970775 | TEMPO CEM (MULTIPLE) | Jun 3, 1997 | Substantially Equivalent |
| K954867 | IONOSIT SEAL | Mar 8, 1996 | Substantially Equivalent |
| K935032 | ZENITH TOTAL ETCH 10% PHOSPHORIC ACID | Jan 18, 1994 | Substantially Equivalent |
| K871562 | IONOCAL | May 20, 1987 | Substantially Equivalent |
| K864898 | FOREMOST DENTIN ADHESIVE | Feb 12, 1987 | Substantially Equivalent |