PERMASEAL

Material, Tooth Shade, Resin

ULTRADENT PRODUCTS, INC.

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

Pre-market Notification Details

• Device ID: K950859
• 510k Number: K950859
• Device Name: PERMASEAL
• Classification: Material, Tooth Shade, Resin
• 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: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-02-27
• Decision Date: 1995-03-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00883205104045	K950859	000
00883205103703	K950859	000
00883205102584	K950859	000