The following data is part of a premarket notification filed by Pentron Clinical Technologies with the FDA for Artiste Se Flowable Composite, Model N280.
| Device ID | K072545 |
| 510k Number | K072545 |
| Device Name: | ARTISTE SE FLOWABLE COMPOSITE, MODEL N280 |
| Classification | Material, Tooth Shade, Resin |
| Applicant | PENTRON CLINICAL TECHNOLOGIES 68-70 NORTH PLAINS INDUSTRIAL ROAD Wallingford, CT 06492 |
| Contact | Greg Moreau |
| Correspondent | Greg Moreau PENTRON CLINICAL TECHNOLOGIES 68-70 NORTH PLAINS INDUSTRIAL ROAD 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 | 2007-09-10 |
| Decision Date | 2007-10-26 |
| Summary: | summary |