SURPASS

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 Surpass.

Pre-market Notification Details

• Device ID: K061981
• 510k Number: K061981
• Device Name: SURPASS
• 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: 2006-07-13
• Decision Date: 2006-07-31
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850194007527	K061981	000
00818207020727	K061981	000
00818207020734	K061981	000
00818207020741	K061981	000
10818207020557	K061981	000
00850194007008	K061981	000
00850194007015	K061981	000
00850194007022	K061981	000
00850194007039	K061981	000
00850194007046	K061981	000
00818207020710	K061981	000