The following data is part of a premarket notification filed by Unitek Corp. with the FDA for Alastik.
| Device ID | K933501 |
| 510k Number | K933501 |
| Device Name: | ALASTIK |
| Classification | Bracket, Metal, Orthodontic |
| Applicant | UNITEK CORP. 2724 SOUTH PECK RD. Monrovia, CA 91016 -5097 |
| Contact | Marlyn Scheff |
| Correspondent | Marlyn Scheff UNITEK CORP. 2724 SOUTH PECK RD. Monrovia, CA 91016 -5097 |
| Product Code | EJF |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-19 |
| Decision Date | 1994-04-28 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ALASTIK 73542299 1439061 Live/Registered |
UNITEK CORPORATION 1985-06-10 |
![]() ALASTIK 72272875 0890975 Dead/Cancelled |
UNITEK CORPORATION 1967-06-01 |