The following data is part of a premarket notification filed by Austenal, Inc. with the FDA for Dc-tell.
Device ID | K001799 |
510k Number | K001799 |
Device Name: | DC-TELL |
Classification | Material, Tooth Shade, Resin |
Applicant | AUSTENAL, INC. 4101 WEST 51ST ST. Chicago, IL 60632 -4287 |
Contact | Ronald Dudek |
Correspondent | Ronald Dudek AUSTENAL, INC. 4101 WEST 51ST ST. Chicago, IL 60632 -4287 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-06-14 |
Decision Date | 2000-08-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DC-TELL 79057131 3643789 Dead/Cancelled |
Bien-Air DCS Solutions AG 2008-08-01 |