The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Ultra-blend.
Device ID | K953524 |
510k Number | K953524 |
Device Name: | ULTRA-BLEND |
Classification | Liner, Cavity, Calcium Hydroxide |
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 | EJK |
CFR Regulation Number | 872.3250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-07-27 |
Decision Date | 1995-08-24 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ULTRA-BLEND 73830843 1599174 Live/Registered |
ULTRADENT PRODUCTS INCORPORATED 1989-10-12 |
ULTRA-BLEND 73746237 1528528 Live/Registered |
EIGHT IN ONE PET PRODUCTS INC. 1988-08-15 |