The following data is part of a premarket notification filed by Union Broach, Div. Moyco Industries, Inc. with the FDA for Union Broach Bleaching Light.
| Device ID | K895174 |
| 510k Number | K895174 |
| Device Name: | UNION BROACH BLEACHING LIGHT |
| Classification | Heat Source For Bleaching Teeth |
| Applicant | UNION BROACH, DIV. MOYCO INDUSTRIES, INC. P.O. BOX 508 ABERDEEN ROAD Emigsville, PA 17318 |
| Contact | Alan P Schwartz |
| Correspondent | Alan P Schwartz UNION BROACH, DIV. MOYCO INDUSTRIES, INC. P.O. BOX 508 ABERDEEN ROAD Emigsville, PA 17318 |
| Product Code | EEG |
| CFR Regulation Number | 872.6475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-07 |
| Decision Date | 1990-04-13 |