The following data is part of a premarket notification filed by Union Broach, Div. Moyco Industries, Inc. with the FDA for Flexor Flexible Roane Tip Endodontic File.
| Device ID | K855136 |
| 510k Number | K855136 |
| Device Name: | FLEXOR FLEXIBLE ROANE TIP ENDODONTIC FILE |
| Classification | File, Pulp Canal, Endodontic |
| Applicant | UNION BROACH, DIV. MOYCO INDUSTRIES, INC. 1107 BROADWAY New York, NY 10010 |
| Contact | Alan Schwartz |
| Correspondent | Alan Schwartz UNION BROACH, DIV. MOYCO INDUSTRIES, INC. 1107 BROADWAY New York, NY 10010 |
| Product Code | EKS |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-23 |
| Decision Date | 1986-03-06 |