The following data is part of a premarket notification filed by Pentron Clinical Technologies with the FDA for Build-it Light Cure.
| Device ID | K091512 |
| 510k Number | K091512 |
| Device Name: | BUILD-IT LIGHT CURE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | PENTRON CLINICAL TECHNOLOGIES 1717 WEST COLLINS AVE Orange, CA 92867 |
| Contact | Wendy Garman |
| Correspondent | Wendy Garman PENTRON CLINICAL TECHNOLOGIES 1717 WEST COLLINS AVE Orange, CA 92867 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-21 |
| Decision Date | 2009-10-30 |
| Summary: | summary |