The following data is part of a premarket notification filed by Jeneric/pentron, Inc. with the FDA for Bio74-pf Crown & Bridge Alloy.
| Device ID | K943487 |
| 510k Number | K943487 |
| Device Name: | BIO74-PF CROWN & BRIDGE ALLOY |
| Classification | Alloy, Gold-based Noble Metal |
| Applicant | JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 -0724 |
| Contact | Linda D Rivard |
| Correspondent | Linda D Rivard JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 -0724 |
| Product Code | EJT |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-19 |
| Decision Date | 1994-08-10 |