The following data is part of a premarket notification filed by Glenroe with the FDA for Glenroe Golden Orthodontic Bracket.
| Device ID | K923124 |
| 510k Number | K923124 |
| Device Name: | GLENROE GOLDEN ORTHODONTIC BRACKET |
| Classification | Bracket, Metal, Orthodontic |
| Applicant | GLENROE 1912 44TH AVENUE E. Bradenton, FL 34203 |
| Contact | John F Bozman |
| Correspondent | John F Bozman GLENROE 1912 44TH AVENUE E. Bradenton, FL 34203 |
| Product Code | EJF |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-26 |
| Decision Date | 1992-08-27 |