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
00359883003791	K092539	000
00359883001421	K092539	000