The following data is part of a premarket notification filed by Thermoelastic Technologies, Inc. with the FDA for Bitem Lock, Models Sw006, Sw012.
| Device ID | K994357 |
| 510k Number | K994357 |
| Device Name: | BITEM LOCK, MODELS SW006, SW012 |
| Classification | Bracket, Metal, Orthodontic |
| Applicant | THERMOELASTIC TECHNOLOGIES, INC. 3234 ELLA LN. New Port Richey, FL 34655 |
| Contact | Art Ward |
| Correspondent | Art Ward THERMOELASTIC TECHNOLOGIES, INC. 3234 ELLA LN. New Port Richey, FL 34655 |
| Product Code | EJF |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-27 |
| Decision Date | 2000-03-14 |
| Summary: | summary |