The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Ultracid Disinfecting Soloution.
Device ID | K953167 |
510k Number | K953167 |
Device Name: | ULTRACID DISINFECTING SOLOUTION |
Classification | Varnish, Cavity |
Applicant | ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
Contact | L. M. Chatwin |
Correspondent | L. M. Chatwin ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
Product Code | LBH |
CFR Regulation Number | 872.3260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-07-07 |
Decision Date | 1995-09-08 |