FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIMI ALLOY
K Number: K844653
·
Decision Mar 25, 1985
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
73
Applicant Total
23
Review Days
116
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Basic Information
- Device Name
- LIMI ALLOY
- K Number
- K844653
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- G-C Intl. Corp.
- Date Received
- November 29, 1984
- Decision Date
- March 25, 1985
- Product Code
- EJJ
- 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 |
|---|---|---|---|
| EJJ | Alloy, Amalgam | 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 |