The following data is part of a premarket notification filed by Analytic Technology with the FDA for Touch-n-heat Model 5001.
| Device ID | K823486 |
| 510k Number | K823486 |
| Device Name: | TOUCH-N-HEAT MODEL 5001 |
| Classification | Gutta-percha |
| Applicant | ANALYTIC TECHNOLOGY 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EKM |
| CFR Regulation Number | 872.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-23 |
| Decision Date | 1983-01-18 |