FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZINFOS ZINC PHOSPHATE CEMENT
K Number: K982913
·
Decision Oct 19, 1998
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
504
Applicant Total
72
Review Days
61
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Basic Information
- Device Name
- ZINFOS ZINC PHOSPHATE CEMENT
- K Number
- K982913
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Scientific Pharmaceuticals, Inc.
- Date Received
- August 19, 1998
- Decision Date
- October 19, 1998
- 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 Scientific Pharmaceuticals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K051952 | EUGENONE | Sep 7, 2005 | Substantially Equivalent |
| K041886 | PROVISO | Aug 4, 2004 | Substantially Equivalent |
| K013555 | SCI-PHARM POST SECURE | Jan 23, 2002 | Substantially Equivalent |
| K001446 | LIGHT-CURED ORTHODONTIC BAND CEMENT | Jul 21, 2000 | Substantially Equivalent |
| K993324 | CARBOCEM ZINC POLYCARBOXYLATE CEMENT | Nov 9, 1999 | Substantially Equivalent |
| K982915 | SCI-PHARM DFV VARNISH | Feb 12, 1999 | Substantially Equivalent |
| K983305 | SCI-PHARM DESENSITIZING VARNISH | Dec 17, 1998 | Substantially Equivalent |
| K944466 | SEALDENT | Mar 2, 1995 | Substantially Equivalent |
| K930584 | MAGNACORE | Feb 22, 1994 | Substantially Equivalent |
| K930583 | MEGABOND SYSTEM | Feb 22, 1994 | Substantially Equivalent |