The following data is part of a premarket notification filed by Unitek Corp. with the FDA for Heated Gutta Percha Delivery System.
| Device ID | K832654 |
| 510k Number | K832654 |
| Device Name: | HEATED GUTTA PERCHA DELIVERY SYSTEM |
| Classification | Gutta-percha |
| Applicant | UNITEK CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EKM |
| CFR Regulation Number | 872.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-08 |
| Decision Date | 1983-09-26 |