The following data is part of a premarket notification filed by Miltex Instrument Co. with the FDA for Files & Reamers.
| Device ID | K812692 |
| 510k Number | K812692 |
| Device Name: | FILES & REAMERS |
| Classification | File, Pulp Canal, Endodontic |
| Applicant | MILTEX INSTRUMENT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EKS |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-22 |
| Decision Date | 1981-10-23 |