The following data is part of a premarket notification filed by Ortho Specialties with the FDA for Regency Tube.
| Device ID | K936243 |
| 510k Number | K936243 |
| Device Name: | REGENCY TUBE |
| Classification | Tube, Orthodontic |
| Applicant | ORTHO SPECIALTIES 9525 SOUTH 79TH AVE. Hickory Hills, IL 60455 |
| Contact | David Brosius |
| Correspondent | David Brosius ORTHO SPECIALTIES 9525 SOUTH 79TH AVE. Hickory Hills, IL 60455 |
| Product Code | DZD |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-30 |
| Decision Date | 1994-02-02 |