The following data is part of a premarket notification filed by Opal Orthodontics By Ultradent Products Inc. with the FDA for Avex Cx2 And Avex Cxi2 Ceramic Brackets.
| Device ID | K113334 |
| 510k Number | K113334 |
| Device Name: | AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS |
| Classification | Bracket, Ceramic, Orthodontic |
| Applicant | OPAL ORTHODONTICS BY ULTRADENT PRODUCTS INC. 10200 SOUTH 505 WEST South Jordan, UT 84095 |
| Contact | Diane Rogers |
| Correspondent | Diane Rogers OPAL ORTHODONTICS BY ULTRADENT PRODUCTS INC. 10200 SOUTH 505 WEST South Jordan, UT 84095 |
| Product Code | NJM |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-14 |
| Decision Date | 2012-02-03 |
| Summary: | summary |