The following data is part of a premarket notification filed by Apex Orthodontics, Inc. with the FDA for Apex Direct Bonded Brackets.
| Device ID | K923440 |
| 510k Number | K923440 |
| Device Name: | APEX DIRECT BONDED BRACKETS |
| Classification | Bracket, Metal, Orthodontic |
| Applicant | APEX ORTHODONTICS, INC. 608 BENT CREEK Desoto, TX 75115 |
| Contact | Oscar Linnstaedter |
| Correspondent | Oscar Linnstaedter APEX ORTHODONTICS, INC. 608 BENT CREEK Desoto, TX 75115 |
| Product Code | EJF |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-13 |
| Decision Date | 1993-03-31 |