The following data is part of a premarket notification filed by Pentron Corp. with the FDA for C-18.
Device ID | K841267 |
510k Number | K841267 |
Device Name: | C-18 |
Classification | Material, Tooth Shade, Resin |
Applicant | PENTRON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-03-26 |
Decision Date | 1984-04-30 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
C-18 75515434 2274294 Dead/Cancelled |
C-18 Corporation 1998-07-08 |