EverX Flow
Material, Tooth Shade, Resin
GC America Inc.
The following data is part of a premarket notification filed by Gc America Inc. with the FDA for Everx Flow.
Pre-market Notification Details
| Device ID | K192260 |
| 510k Number | K192260 |
| Device Name: | EverX Flow |
| Classification | Material, Tooth Shade, 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 | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-21 |
| Decision Date | 2019-11-22 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D0470128991 | K192260 | 000 |
| D0470128981 | K192260 | 000 |
| 14548161292788 | K192260 | 000 |
Trademark Results [EverX Flow]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EVERX FLOW 88163782 not registered Live/Pending |
GC CORPORATION 2018-10-22 |
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