The following data is part of a premarket notification filed by Alpha-dent with the FDA for Centrix's Encore Solo Light Activated Resin Core.
Device ID | K932828 |
510k Number | K932828 |
Device Name: | CENTRIX'S ENCORE SOLO LIGHT ACTIVATED RESIN CORE |
Classification | Material, Tooth Shade, Resin |
Applicant | ALPHA-DENT 1920 N. CLYBOURN AVE. Chicago, IL 60614 |
Contact | George Nicolae |
Correspondent | George Nicolae ALPHA-DENT 1920 N. CLYBOURN AVE. Chicago, IL 60614 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-09 |
Decision Date | 1994-02-03 |