The following data is part of a premarket notification filed by Union Broach, Div. Moyco Industries, Inc. with the FDA for Root Canal Files, Type H (hedstrom.
| Device ID | K822622 |
| 510k Number | K822622 |
| Device Name: | ROOT CANAL FILES, TYPE H (HEDSTROM |
| Classification | File, Pulp Canal, Endodontic |
| Applicant | UNION BROACH, DIV. MOYCO INDUSTRIES, INC. 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 | 1982-08-30 |
| Decision Date | 1982-09-28 |