The following data is part of a premarket notification filed by Jeneric/pentron, Inc. with the FDA for Fiberlite, Fiberlite Hs And Fiberseal.
| Device ID | K884038 |
| 510k Number | K884038 |
| Device Name: | FIBERLITE, FIBERLITE HS AND FIBERSEAL |
| Classification | Material, Tooth Shade, Resin |
| Applicant | JENERIC/PENTRON, INC. 53 N. PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 |
| Contact | Waknine, Dms |
| Correspondent | Waknine, Dms JENERIC/PENTRON, INC. 53 N. 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 | 1988-09-26 |
| Decision Date | 1988-12-07 |