The following data is part of a premarket notification filed by Gresco Products, Inc. with the FDA for Kar-d-tek.
| Device ID | K913405 |
| 510k Number | K913405 |
| Device Name: | KAR-D-TEK |
| Classification | Device, Caries Detection |
| Applicant | GRESCO PRODUCTS, INC. P.O. BOX 865 12603 EXECUTIVE DR. #814 Stafford, TX 77497 |
| Contact | Clinton D Vaupel |
| Correspondent | Clinton D Vaupel GRESCO PRODUCTS, INC. P.O. BOX 865 12603 EXECUTIVE DR. #814 Stafford, TX 77497 |
| Product Code | LFC |
| CFR Regulation Number | 872.1740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-30 |
| Decision Date | 1991-10-28 |