The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Permaflo.
Device ID | K974413 |
510k Number | K974413 |
Device Name: | PERMAFLO |
Classification | Material, Tooth Shade, Resin |
Applicant | ULTRADENT PRODUCTS, INC. 505 W. 10200 SO. South Jordan, UT 84095 -3935 |
Contact | Chester Mccoy |
Correspondent | Chester Mccoy ULTRADENT PRODUCTS, INC. 505 W. 10200 SO. South Jordan, UT 84095 -3935 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-11-24 |
Decision Date | 1998-02-02 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00883205104113 | K974413 | 000 |
00883205103871 | K974413 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PERMAFLO 85775420 not registered Dead/Abandoned |
Indiana Soybean Alliance, Inc. 2012-11-09 |
PERMAFLO 78412336 2970438 Live/Registered |
Permatron Corporation 2004-05-03 |
PERMAFLO 78079794 2728155 Live/Registered |
NORDSON CORPORATION 2001-08-17 |
PERMAFLO 77717191 not registered Dead/Abandoned |
Indiana Soybean Alliance, Inc. 2009-04-20 |
PERMAFLO 75564695 2290253 Live/Registered |
ULTRADENT PRODUCTS, INC. 1998-10-05 |
PERMAFLO 72393694 0979651 Dead/Expired |
PERMEATOR CORPORATION 1971-06-01 |