FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
G-C FIT-CHECKER IMPRESSION MATERIAL
K Number: K812679
·
Decision Oct 6, 1981
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
401
Applicant Total
23
Review Days
14
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Basic Information
- Device Name
- G-C FIT-CHECKER IMPRESSION MATERIAL
- K Number
- K812679
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- G-C Intl. Corp.
- Date Received
- September 22, 1981
- Decision Date
- October 6, 1981
- Product Code
- ELW
- 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 |
|---|---|---|---|
| ELW | Material, Impression | FDA class 2 | Dental |
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Other Clearances by G-C Intl. Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K913175 | MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULES | Dec 27, 1991 | Substantially Equivalent |
| K913884 | FUJI II LC | Oct 30, 1991 | Substantially Equivalent |
| K901999 | FUJI LINING CEMENT LIGHT CURE | Jul 31, 1990 | Substantially Equivalent |
| K902531 | EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL | Jul 13, 1990 | Substantially Equivalent |
| K896883 | GC CERVICAL CEMENT | Jul 6, 1990 | Substantially Equivalent |
| K895976 | TOOTH SHADE RESIN | Dec 22, 1989 | Substantially Equivalent |
| K892806 | TUF-COAT | Jul 14, 1989 | Substantially Equivalent |
| K890830 | DENTURE RESIN | May 1, 1989 | Substantially Equivalent |
| K890829 | UNIFAST LC | Apr 17, 1989 | Substantially Equivalent |
| K883770 | RESUBMITTED EMA DENTIN CEMENT | Nov 30, 1988 | Substantially Equivalent |