The following data is part of a premarket notification filed by Gc America Inc. with the FDA for Gc Acrylic Primer.
Device ID | K180917 |
510k Number | K180917 |
Device Name: | GC Acrylic Primer |
Classification | Agent, Tooth Bonding, Resin |
Applicant | GC America Inc. 3737 W. 127th Street Alsip, IL 60803 |
Contact | Mark Heiss |
Correspondent | Mark Heiss GC America Inc. 3737 W. 127th Street Alsip, IL 60803 |
Product Code | KLE |
CFR Regulation Number | 872.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-04-09 |
Decision Date | 2018-11-20 |
Summary: | summary |