FEI 1410097
Gc America Inc.
3737 W 127th St, ALSIP, IL, US
MDR events24All time
Recalls0All time
Registered products38
Establishment typeRepackRepack or Relabel Medical Device
Registered product codes
38 product codes
Recent MDR events
24 on file
- MI PASTE PLUS MINT TOPICAL PASTE WITH BIO-AVAILABLESep 22, 2025InjuryMW5176273
- MI PASTE PLUS MINT TOPICAL PASTE WITH BIO-AVAILABLESep 22, 2025InjuryMW5176274
- MI PASTE PLUS MINT TOPICAL PASTE WITH BIO-AVAILABLESep 22, 2025InjuryMW5176278
- MI VARNISHJan 31, 2025InjuryMW5165603
- COE-SOFTAug 28, 2024OtherMW5159016
- GC TOOTH MOUSSE ( MARKETED IN THE U.S. UNDER BRAND NAME "MI PASTE")Apr 3, 2019Death1410097-2019-00002
- EXA'LENCE REGULAR HEAVY 48 MLFeb 27, 2018Injury1410097-2018-00001
- COE-SOFT 5.5 OZ PROFESSIONAL PACKAGEJun 1, 2017Injury1410097-2017-00002
- ALIKE 4OZ LIQUIDJun 1, 2017Injury1410097-2017-00001
- COE-SOFTNov 3, 2016Injury1410097-2016-00003
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 1410097.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
3 on file
Top refusal reasons
Compare to industry ↗- Division of Northeast Imports (DNEI)Jul 10, 2026
76EBI \ RESIN, DENTURE, RELINING, REPAIRING, REBASING
- Division of West Coast Imports (DWCI)Oct 15, 2025
76EBZ \ ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION
- Division of Northeast Imports (DNEI)Oct 18, 2023
76EBI \ RESIN, DENTURE, RELINING, REPAIRING, REBASING