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
EJJ Alloy, Amalgam

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Other Clearances by G-C Intl. Corp.

K Number Device Name
K913175 MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULES
K913884 FUJI II LC
K901999 FUJI LINING CEMENT LIGHT CURE
K902531 EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL
K896883 GC CERVICAL CEMENT
K895976 TOOTH SHADE RESIN
K892806 TUF-COAT
K890830 DENTURE RESIN
K890829 UNIFAST LC
K883770 RESUBMITTED EMA DENTIN CEMENT
Search all 23 clearances from G-C Intl. Corp. →