The following data is part of a premarket notification filed by Dale T. Dupuis with the FDA for Amorphus Silk By Dentrax.
| Device ID | K882400 |
| 510k Number | K882400 |
| Device Name: | AMORPHUS SILK BY DENTRAX |
| Classification | Material, Tooth Shade, Resin |
| Applicant | DALE T. DUPUIS 912 NORTH UNION Opelousas, LA 70570 |
| Contact | Dupuis, Dds |
| Correspondent | Dupuis, Dds DALE T. DUPUIS 912 NORTH UNION Opelousas, LA 70570 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-10 |
| Decision Date | 1988-07-15 |