The following data is part of a premarket notification filed by Ormco Corp. with the FDA for The Bracket Assembly With A Security System.
| Device ID | K905197 |
| 510k Number | K905197 |
| Device Name: | THE BRACKET ASSEMBLY WITH A SECURITY SYSTEM |
| Classification | Alloy, Gold-based Noble Metal |
| 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 | EJT |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-20 |
| Decision Date | 1990-12-27 |