Not currently registered with FDA under this name

Apex Dental Materials, Inc.

Lake Zurich, IL, United States. Named as applicant on 15 dental 510(k) clearances between 2001 and 2019. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 152001–2019
Markets registered in: 1United States
Establishments: 0—

510(k) clearances per year, 2000–2026

510(k) clearances

Clearances on which FDA names Apex Dental Materials, Inc. as the applicant.

Decided	510(k)	Device	Device type
8 Nov 2019	K190998	BA Pit & Fissure Sealant	EBC Pit and Fissure Sealant and Conditioner
17 Mar 2017	K161077	RnD TE and RnD SE	KLE Resin Tooth Bonding Agent
10 Sep 2013	K131043	APEX UNIVERSAL ADHESIVE	KLE Resin Tooth Bonding Agent
27 Aug 2013	K131049	ZRP	KLE Resin Tooth Bonding Agent
31 May 2012	K120620	CLEAN AND BOOST	KLE Resin Tooth Bonding Agent
23 Jun 2011	K110859	METAL OPAQUER	EBF Resin Tooth Shade Material
1 Oct 2009	K092539	SEAMFREE	EBF Resin Tooth Shade Material
21 Sep 2009	K091647	INJECTAFIL	EBF Resin Tooth Shade Material
13 Oct 2006	K062157	CONFORM	EBF Resin Tooth Shade Material
31 Jul 2006	K061981	SURPASS	KLE Resin Tooth Bonding Agent
1 Feb 2006	K053103	INTERFACE	KLE Resin Tooth Bonding Agent
24 Apr 2002	K020570	SIMPLICITY	KLE Resin Tooth Bonding Agent
14 Sep 2001	K010849	VERTEX ETCHANT	EBF Resin Tooth Shade Material
16 Aug 2001	K010547	VERTEX SEALAND L/C ORTHODONTIC SEALANT	KLE Resin Tooth Bonding Agent
10 Aug 2001	K010544	VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE	DYH Resin Bracket and Tooth Conditioner Adhesive

Some of these clearances are listed with FDA today by another company: Inter-Med, Inc. (12), Den-Mat Holdings, LLC (2), Xplora USA LLC (1).

Sources

FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.