The following data is part of a premarket notification filed by Union Broach, Div. Moyco Industries, Inc. with the FDA for Inject-r Fill.
| Device ID | K931742 |
| 510k Number | K931742 |
| Device Name: | INJECT-R FILL |
| Classification | Gutta-percha |
| 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 | EKM |
| CFR Regulation Number | 872.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-07 |
| Decision Date | 1993-05-27 |