The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Htfx-222.
| Device ID | K133182 |
| 510k Number | K133182 |
| Device Name: | HTFX-222 |
| Classification | Material, Tooth Shade, Resin |
| Applicant | GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Contact | Mark Heiss |
| Correspondent | Mark Heiss GC AMERICA, INC. 3737 WEST 127TH ST. 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 | 2013-10-17 |
| Decision Date | 2014-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14548161325677 | K133182 | 000 |
| 14548161325660 | K133182 | 000 |
| 14548161325653 | K133182 | 000 |
| 14548161325646 | K133182 | 000 |
| 14548161325639 | K133182 | 000 |
| 14548161325622 | K133182 | 000 |
| 14548161325615 | K133182 | 000 |
| 14548161325608 | K133182 | 000 |