The following data is part of a premarket notification filed by Imtec Corp. with the FDA for Hexlock/hexlock Screw.
| Device ID | K932168 |
| 510k Number | K932168 |
| Device Name: | HEXLOCK/HEXLOCK SCREW |
| Classification | Implant, Endosseous, Root-form |
| Applicant | IMTEC CORP. 2007 N. COMMERCE P.O. BOX 1562 Ardmore, OK 73402 |
| Contact | Gillespie |
| Correspondent | Gillespie IMTEC CORP. 2007 N. COMMERCE P.O. BOX 1562 Ardmore, OK 73402 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-05 |
| Decision Date | 1994-08-24 |