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 |