The following data is part of a premarket notification filed by Duradent Corp. with the FDA for Distaflex.
Device ID | K823280 |
510k Number | K823280 |
Device Name: | DISTAFLEX |
Classification | Attachment, Precision, All |
Applicant | DURADENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EGG |
CFR Regulation Number | 872.3165 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-11-03 |
Decision Date | 1982-11-22 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DISTAFLEX 77928740 4415099 Live/Registered |
BOSTON SCIENTIFIC LIMITED 2010-02-05 |
DISTAFLEX 74048578 1633103 Dead/Cancelled |
Medtronic, Inc. 1990-04-13 |