The following data is part of a premarket notification filed by Dontech Products B.v. with the FDA for T-gear, Model Tg/400-700.
| Device ID | K993224 |
| 510k Number | K993224 |
| Device Name: | T-GEAR, MODEL TG/400-700 |
| Classification | Headgear, Extraoral, Orthodontic |
| Applicant | DONTECH PRODUCTS B.V. AVELINGENWEST 27C Gorinchem, Zh, NL |
| Contact | Jan Jorens |
| Correspondent | Jan Jorens DONTECH PRODUCTS B.V. AVELINGENWEST 27C Gorinchem, Zh, NL |
| Product Code | DZB |
| CFR Regulation Number | 872.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-27 |
| Decision Date | 2000-02-11 |