CLEARTEMP

Cement, Dental

ULTRADENT PRODUCTS, INC.

The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Cleartemp.

Pre-market Notification Details

• Device ID: K111017
• 510k Number: K111017
• Device Name: CLEARTEMP
• Classification: Cement, Dental
• Applicant: ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095
• Contact: Diane Rogers
• Correspondent: Diane Rogers; ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095
• Product Code: EMA
• CFR Regulation Number: 872.3275 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-04-12
• Decision Date: 2011-06-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00883205106674	K111017	000
00883205102744	K111017	000