INTERFACE

Agent, Tooth Bonding, Resin

APEX DENTAL MATERIALS, INC.

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

Pre-market Notification Details

• Device ID: K053103
• 510k Number: K053103
• Device Name: INTERFACE
• Classification: Agent, Tooth Bonding, Resin
• Applicant: APEX DENTAL MATERIALS, INC. 23329 MALLARD COURT Deer Park, IL 60010
• Contact: Chris Kulton
• Correspondent: Chris Kulton; APEX DENTAL MATERIALS, INC. 23329 MALLARD COURT Deer Park, IL 60010
• Product Code: KLE
• CFR Regulation Number: 872.3200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-11-04
• Decision Date: 2006-02-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850194007725	K053103	000
00850194007718	K053103	000
00850194007350	K053103	000
00850194007893	K053103	000