The following data is part of a premarket notification filed by Ormco Corp. with the FDA for Lumina Orthodontic Bracket.
| Device ID | K894358 |
| 510k Number | K894358 |
| Device Name: | LUMINA ORTHODONTIC BRACKET |
| Classification | Bracket, Metal, Orthodontic |
| Applicant | ORMCO CORP. 1332 SOUTH LONE HILL AVE. Glendora, CA 91740 |
| Contact | Frances Zee |
| Correspondent | Frances Zee ORMCO CORP. 1332 SOUTH LONE HILL AVE. Glendora, CA 91740 |
| Product Code | EJF |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-14 |
| Decision Date | 1989-09-15 |