The following data is part of a premarket notification filed by Orthotech with the FDA for Orthotech Dura-gold Barckets.
| Device ID | K933080 |
| 510k Number | K933080 |
| Device Name: | ORTHOTECH DURA-GOLD BARCKETS |
| Classification | Bracket, Metal, Orthodontic |
| Applicant | ORTHOTECH 5121 EHRLICH RD. SUITE 102-B Tampa, FL 33624 |
| Contact | Brian Leaghty |
| Correspondent | Brian Leaghty ORTHOTECH 5121 EHRLICH RD. SUITE 102-B Tampa, FL 33624 |
| Product Code | EJF |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-23 |
| Decision Date | 1994-03-23 |