CONFORM

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 Conform.

Pre-market Notification Details

• Device ID: K062157
• 510k Number: K062157
• Device Name: CONFORM
• Classification: Material, Tooth Shade, 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: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-07-28
• Decision Date: 2006-10-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850194007756	K062157	000
00850194007091	K062157	000
00818207020826	K062157	000
00818207020819	K062157	000
00818207020802	K062157	000
00818207020796	K062157	000
00818207020789	K062157	000
00818207020772	K062157	000
00818207020765	K062157	000
00818207020758	K062157	000
00818207020703	K062157	000
00818207020697	K062157	000
00818207020680	K062157	000
00818207020673	K062157	000
00818207020666	K062157	000
00850194007107	K062157	000
00850194007114	K062157	000
00850194007251	K062157	000
00850194007244	K062157	000
00850194007237	K062157	000
00850194007220	K062157	000
00850194007213	K062157	000
00850194007206	K062157	000
00850194007190	K062157	000
00850194007183	K062157	000
00850194007176	K062157	000
00850194007169	K062157	000
00850194007152	K062157	000
00850194007145	K062157	000
00850194007138	K062157	000
00850194007121	K062157	000
00818207020055	K062157	000