SEAMFREE

Material, Tooth Shade, Resin

APEX DENTAL MATERIALS, INC.

The following data is part of a premarket notification filed by Apex Dental Materials, Inc. with the FDA for Seamfree.

Pre-market Notification Details

• Device ID: K092539
• 510k Number: K092539
• Device Name: SEAMFREE
• Classification: Material, Tooth Shade, Resin
• Applicant: APEX DENTAL MATERIALS, INC. 330 TELSER ROAD Lake Zurich, IL 60047
• Contact: Chris Kulton
• Correspondent: Chris Kulton; APEX DENTAL MATERIALS, INC. 330 TELSER ROAD Lake Zurich, IL 60047
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-08-19
• Decision Date: 2009-10-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850194007343	K092539	000
00850194007336	K092539	000
00850194007329	K092539	000
00850194007947	K092539	000
00850194007886	K092539	000
00850194007879	K092539	000