The following data is part of a premarket notification filed by Jeneric/pentron, Inc. with the FDA for Sculpture Flow.
| Device ID | K001623 |
| 510k Number | K001623 |
| Device Name: | SCULPTURE FLOW |
| Classification | Material, Tooth Shade, Resin |
| Applicant | JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL ROAD Wallingford, CT 06492 -0724 |
| Contact | Annmarie Tenero |
| Correspondent | Annmarie Tenero JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL ROAD Wallingford, CT 06492 -0724 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-26 |
| Decision Date | 2000-07-11 |