The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Prepquick.
Device ID | K974786 |
510k Number | K974786 |
Device Name: | PREPQUICK |
Classification | Agent, Tooth Bonding, 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 | KLE |
CFR Regulation Number | 872.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-12-22 |
Decision Date | 1998-03-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() PREPQUICK 75399363 2300614 Dead/Cancelled |
ULTRADENT PRODUCTS, INC. 1997-12-02 |