SIMPLICITY

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 Simplicity.

Pre-market Notification Details

• Device ID: K020570
• 510k Number: K020570
• Device Name: SIMPLICITY
• Classification: Agent, Tooth Bonding, Resin
• Applicant: APEX DENTAL MATERIALS, INC. 603 BERKLEY COURT Schaumburg, IL 60194
• Contact: Chris Kulton
• Correspondent: Chris Kulton; APEX DENTAL MATERIALS, INC. 603 BERKLEY COURT Schaumburg, IL 60194
• Product Code: KLE
• CFR Regulation Number: 872.3200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-02-21
• Decision Date: 2002-04-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850194007534	K020570	000
00850194007084	K020570	000
00850194007077	K020570	000
00850194007060	K020570	000
00850194007053	K020570	000
00850194007985	K020570	000
00850194007978	K020570	000
00850194007930	K020570	000
00850194007923	K020570	000