The following data is part of a premarket notification filed by Pentron Corp. with the FDA for Dual-cure Radiopaque.
| Device ID | K874189 |
| 510k Number | K874189 |
| Device Name: | DUAL-CURE RADIOPAQUE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | PENTRON CORP. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 |
| Contact | Martin L Schulman |
| Correspondent | Martin L Schulman PENTRON CORP. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-14 |
| Decision Date | 1988-02-11 |