ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399

Resin, Root Canal Filling

ULTRADENT PRODUCTS, INC.

The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Endorez Obturation Kit (with Accelerator), Model 403, Endorez Accelerator (refill), Model 399.

Pre-market Notification Details

• Device ID: K071106
• 510k Number: K071106
• Device Name: ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399
• Classification: Resin, Root Canal Filling
• Applicant: ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095
• Contact: Corey Jaseph
• Correspondent: Corey Jaseph; ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095
• Product Code: KIF
• CFR Regulation Number: 872.3820 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-04-19
• Decision Date: 2007-05-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00883205107930	K071106	000