Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1203976012
Device Listing 1203976012
Listing Summary
#
Listing key
1203976012
Premarket submission
K151541
Device
G-Fix
Applicant
GC America, Inc.
Product code
EBF
Decision date
2015-10-09
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
10508
1410097
1410097
GC AMERICA INC.
1
Y
2026-01-01
3737 W 127th St ALSIP IL US 60803
10509
9613953
3002807052
GC DENTAL PRODUCTS CORP.
1
N
2026-01-01
2-285 TORIIMATSU-CHO KASUGAI-SHI Aichi JP 486-0844