The following data is part of a premarket notification filed by Union Broach, Div. Moyco Industries, Inc. with the FDA for Nickel-titanium K-type File.
| Device ID | K935542 |
| 510k Number | K935542 |
| Device Name: | NICKEL-TITANIUM K-TYPE FILE |
| Classification | File, Pulp Canal, Endodontic |
| Applicant | UNION BROACH, DIV. MOYCO INDUSTRIES, INC. P.O. BOX 508 ABERDEEN ROAD Emigsville, PA 17318 |
| Contact | Chris M Lehr |
| Correspondent | Chris M Lehr UNION BROACH, DIV. MOYCO INDUSTRIES, INC. P.O. BOX 508 ABERDEEN ROAD Emigsville, PA 17318 |
| Product Code | EKS |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-16 |
| Decision Date | 1994-01-03 |