FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SCI-PHARM PAINT-ON RESTORATIVE
K Number: K801797
·
Decision Aug 7, 1980
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
72
Review Days
9
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Basic Information
- Device Name
- SCI-PHARM PAINT-ON RESTORATIVE
- K Number
- K801797
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Scientific Pharmaceuticals, Inc.
- Date Received
- July 29, 1980
- Decision Date
- August 7, 1980
- Product Code
- EBF
- 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | FDA class 2 | Dental |
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| K982915 | SCI-PHARM DFV VARNISH | Feb 12, 1999 | Substantially Equivalent |
| K983305 | SCI-PHARM DESENSITIZING VARNISH | Dec 17, 1998 | Substantially Equivalent |
| K982913 | ZINFOS ZINC PHOSPHATE CEMENT | Oct 19, 1998 | Substantially Equivalent |
| K944466 | SEALDENT | Mar 2, 1995 | Substantially Equivalent |
| K930584 | MAGNACORE | Feb 22, 1994 | Substantially Equivalent |