The following data is part of a premarket notification filed by Pentron Clinical with the FDA for Build-it Total Core.
| Device ID | K102703 |
| 510k Number | K102703 |
| Device Name: | BUILD-IT TOTAL CORE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | PENTRON CLINICAL 1717 WEST COLLINS AVENUE Orange, CA 92867 |
| Contact | Wendy Garman |
| Correspondent | Wendy Garman PENTRON CLINICAL 1717 WEST COLLINS AVENUE 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 | 2010-09-20 |
| Decision Date | 2011-01-05 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BUILD-IT TOTAL CORE 85174835 not registered Dead/Abandoned |
Pentron Clinical Technologies, LLC 2010-11-11 |