The following data is part of a premarket notification filed by Mid-american Dental Specialties, Inc. with the FDA for Regency Plus Bracket.
| Device ID | K933758 |
| 510k Number | K933758 |
| Device Name: | REGENCY PLUS BRACKET |
| Classification | Bracket, Metal, Orthodontic |
| Applicant | MID-AMERICAN DENTAL SPECIALTIES, INC. 9525 SOUTH 79TH AVE. Hickory Hills, IL 60457 |
| Contact | David Brosius |
| Correspondent | David Brosius MID-AMERICAN DENTAL SPECIALTIES, INC. 9525 SOUTH 79TH AVE. Hickory Hills, IL 60457 |
| Product Code | EJF |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-03 |
| Decision Date | 1994-01-18 |