Apex Dental Materials Inc

FDA Filings

This page includes the latest FDA filings for Apex Dental Materials Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3005372132
• FEI Number: 3005372132
• Name: Apex Dental Materials, Inc
• Owner & Operator: APEX DENTAL MATERIALS, INC.
• Contact Address: 2200 South St Ste A --; Racine WI 53404 US
• Official Correspondent:
  • SCOTT - LAMERAND
  • x-877-2739123-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2200 South St Ste A ; Racine, WI 53404 US
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00850194007985 APEX DENTAL MATERIALS INCORPORATED	V-Force Twin Refill Bottle 2	2019-12-23
GUDID 00850194007978 APEX DENTAL MATERIALS INCORPORATED	V-Force Twin Refill Bottle 1	2019-12-23
GUDID 00850194007961 APEX DENTAL MATERIALS INCORPORATED	Purify+ Liquid Single Pack	2019-12-23
GUDID 00850194007954 APEX DENTAL MATERIALS INCORPORATED	Purify+ Gel Single Pack	2019-12-23
GUDID 00850194007947 APEX DENTAL MATERIALS INCORPORATED	Seamless Single Syringe Pack with Tips	2019-12-23
GUDID 00850194007930 APEX DENTAL MATERIALS INCORPORATED	V-Force Twin Refill Bottle Set	2019-12-23
GUDID 00850194007923 APEX DENTAL MATERIALS INCORPORATED	V-Force Twin Kit Self Etch Dental Adhesive System	2019-12-23
GUDID 00850194007916 APEX DENTAL MATERIALS INCORPORATED	V-Force Solo Universal Adhesive Refill Kit	2019-12-23
GUDID 00850194007909 APEX DENTAL MATERIALS INCORPORATED	V-Force Solo Universal Adhesive Kit	2019-12-23
GUDID 00850194007893 APEX DENTAL MATERIALS INCORPORATED	Omni Etch Ceramic Etch and Silane	2019-12-23
GUDID 00850194007886 APEX DENTAL MATERIALS INCORPORATED	Seamless Kit - Wetting Resin 3ml Bottle	2019-12-23
GUDID 00850194007879 APEX DENTAL MATERIALS INCORPORATED	Seamless Syringe 5 Pack with Tips	2019-12-23
GUDID 00850194007862 APEX DENTAL MATERIALS INCORPORATED	Desensify	2019-12-23
GUDID 00850194007855 APEX DENTAL MATERIALS INCORPORATED	VistaCORE 25ml Cartridge Kit Shade White Opaque	2019-12-23
GUDID 00850194007848 APEX DENTAL MATERIALS INCORPORATED	VistaCORE 25ml Cartridge Kit Shade A2	2019-12-23
GUDID 00850194007831 APEX DENTAL MATERIALS INCORPORATED	VistaCORE 25ml Cartridge Shade A2	2019-12-23
GUDID 00850194007824 APEX DENTAL MATERIALS INCORPORATED	VistaCORE 25ml Cartridge Shade White Opaque	2019-12-23
GUDID 00850194007817 APEX DENTAL MATERIALS INCORPORATED	VistaCORE 5ml Syringe Shade White Opaque	2019-12-23
GUDID 00850194007800 APEX DENTAL MATERIALS INCORPORATED	VistaCORE 5ml Syringe Shade A2	2019-12-23
GUDID 00850194007794 APEX DENTAL MATERIALS INCORPORATED	Purify+ Liquid 5 Pack	2019-12-23
GUDID 00850194007787 APEX DENTAL MATERIALS INCORPORATED	Purify+ Gel 5 Pack	2019-12-23
GUDID 00850194007756 APEX DENTAL MATERIALS INCORPORATED	RE-GEN Flowable Composite Shade A2 90648	2019-12-16
GUDID 00850194007749 APEX DENTAL MATERIALS INCORPORATED	DesensiMAX 90413	2019-12-16
GUDID 00850194007527 APEX DENTAL MATERIALS INCORPORATED	RE-GEN Self Etch Adhesive Kit 90632	2019-12-16
GUDID 00850194007510 APEX DENTAL MATERIALS INCORPORATED	RE-GEN Bulk Fill Composite and Resin Cement Kit A4 90661	2019-12-16
GUDID 00850194007503 APEX DENTAL MATERIALS INCORPORATED	RE-GEN Bulk Fill Composite and Resin Cement A2 Refill 90658	2019-12-16
GUDID 00850194007497 APEX DENTAL MATERIALS INCORPORATED	RE-GEN Bulk Fill Composite and Resin Cement Kit A2 90660	2019-12-16
GUDID 00850194007480 APEX DENTAL MATERIALS INCORPORATED	RE-GEN Pit & Fissure Sealant 90662	2019-12-16
GUDID 00850194007473 APEX DENTAL MATERIALS INCORPORATED	RE-GEN Universal Adhesive Kit 90637	2019-12-16
GUDID 00850194007466 APEX DENTAL MATERIALS INCORPORATED	RE-GEN Cleanser 90719	2019-12-16
GUDID 00850194007152 APEX DENTAL MATERIALS INCORPORATED	Vista Zirconia Primer 4ml Bottle 90577-2	2019-12-16
GUDID 00850194007138 APEX DENTAL MATERIALS INCORPORATED	Vista Zirconia Primer 2ml Syringe 90578-2	2019-12-16
GUDID 00850194007091 APEX DENTAL MATERIALS INCORPORATED	RE-GEN Flowable Composite Shade A1 90639	2019-12-16
PMN K190998 Apex Dental Materials, Inc.	BA Pit & Fissure Sealant	2019-11-08
GUDID 00850194007312 APEX DENTAL MATERIALS INCORPORATED	Clean & Boost Gel 5 Pack 135-02	2018-10-05
GUDID 00850194007305 APEX DENTAL MATERIALS INCORPORATED	Clean & Boost Liquid 5 Pack 135-01	2018-10-05
GUDID 00850194007299 APEX DENTAL MATERIALS INCORPORATED	Clean & Boost Liquid Single Syringe Pack 135-00	2018-10-05
GUDID 00850194007282 APEX DENTAL MATERIALS INCORPORATED	Clean & Boost Gel Single Syringe Pack 135-03	2018-10-05
GUDID 00850194007732 APEX DENTAL MATERIALS INCORPORATED	BondSaver 125-00	2018-07-06
GUDID 00850194007725 APEX DENTAL MATERIALS INCORPORATED	Interface B Bottle 105-00-B	2018-07-06
GUDID 00850194007718 APEX DENTAL MATERIALS INCORPORATED	Interface A Bottle 105-00-A	2018-07-06
GUDID 00850194007701 APEX DENTAL MATERIALS INCORPORATED	Exquisite Restoration Unit Dose Sample Pack (5 per Pack) 171-S-UD	2018-07-06
GUDID 00850194007695 APEX DENTAL MATERIALS INCORPORATED	Exquisite Restoration Unit Dose Shade Incisal (20 per Pack) 171-I-UD	2018-07-06
GUDID 00850194007688 APEX DENTAL MATERIALS INCORPORATED	Exquisite Restoration Unit Dose Shade D3 (20 per Pack) 171-D3-UD	2018-07-06
GUDID 00850194007671 APEX DENTAL MATERIALS INCORPORATED	Exquisite Restoration Unit Dose Shade D2 (20 per Pack) 171-D2-UD	2018-07-06
GUDID 00850194007664 APEX DENTAL MATERIALS INCORPORATED	Exquisite Restoration Unit Dose Shade B1 (20 per Pack) 171-B1-UD	2018-07-06
GUDID 00850194007657 APEX DENTAL MATERIALS INCORPORATED	Exquisite Restoration Unit Dose Shade A4 (20 per Pack) 171-A4-UD	2018-07-06
GUDID 00850194007640 APEX DENTAL MATERIALS INCORPORATED	Exquisite Restoration Unit Dose Shade A3 (20 per Pack) 171-A3-UD	2018-07-06
GUDID 00850194007633 APEX DENTAL MATERIALS INCORPORATED	Exquisite Restoration Unit Dose Shade A2 (20 per Pack) 171-A2-UD	2018-07-06
GUDID 00850194007626 APEX DENTAL MATERIALS INCORPORATED	Exquisite Restoration Unit Dose Shade A1 (20 per Pack) 171-A1-UD	2018-07-06
GUDID 00850194007619 APEX DENTAL MATERIALS INCORPORATED	Exquisite Restoration Syringe Shade Incisal 170-I-Syr	2018-07-06
GUDID 00850194007602 APEX DENTAL MATERIALS INCORPORATED	Exquisite Restoration Syringe Shade D3 170-D3-Syr	2018-07-06
GUDID 00850194007596 APEX DENTAL MATERIALS INCORPORATED	Exquisite Restoration Syringe Shade D2 170-D2-Syr	2018-07-06
GUDID 00850194007589 APEX DENTAL MATERIALS INCORPORATED	Exquisite Restoration Syringe Shade B1 170-B1-Syr	2018-07-06
GUDID 00850194007572 APEX DENTAL MATERIALS INCORPORATED	Exquisite Restoration Syringe Shade A4 170-A4-Syr	2018-07-06
GUDID 00850194007565 APEX DENTAL MATERIALS INCORPORATED	Exquisite Restoration Syringe Shade A3 170-A3-Syr	2018-07-06
GUDID 00850194007558 APEX DENTAL MATERIALS INCORPORATED	Exquisite Restoration Syringe Shade A2 170-A2-Syr	2018-07-06
GUDID 00850194007541 APEX DENTAL MATERIALS INCORPORATED	Exquisite Restoration Syringe Shade A1 170-A1-Syr	2018-07-06
GUDID 00850194007534 APEX DENTAL MATERIALS INCORPORATED	Simplicity Kit: Original 100-50	2018-07-06
GUDID 00850194007459 APEX DENTAL MATERIALS INCORPORATED	Anchor 5ml Syringe Shade White Opaque 110-W-5	2018-07-06
GUDID 00850194007442 APEX DENTAL MATERIALS INCORPORATED	Anchor 5ml Syringe Shade A2 110-A2-5	2018-07-06
GUDID 00850194007435 APEX DENTAL MATERIALS INCORPORATED	Anchor 25ml Cartridge Refill Kit Shade A2 111-A2-25	2018-07-06
GUDID 00850194007428 APEX DENTAL MATERIALS INCORPORATED	Anchor 25ml Cartridge Refill Kit Shade White Opaque 111-W-25	2018-07-06
GUDID 00850194007411 APEX DENTAL MATERIALS INCORPORATED	Anchor 25ml Cartridge Kit Shade White Opaque 113-W-Kit	2018-07-06
GUDID 00850194007404 APEX DENTAL MATERIALS INCORPORATED	Anchor 25ml Cartridge Kit Shade A2 113-A2-Kit	2018-07-06
GUDID 00850194007398 APEX DENTAL MATERIALS INCORPORATED	Injectafil A4 Syringe Refill with Tips 107-A4-Refill	2018-07-06
GUDID 00850194007381 APEX DENTAL MATERIALS INCORPORATED	Injectafil A2 Syringe Refill with Tips 107-A2-Refill	2018-07-06
GUDID 00850194007374 APEX DENTAL MATERIALS INCORPORATED	Injectafil A4 Syringe with Extrusion Handle 106-A4-Kit	2018-07-06
GUDID 00850194007367 APEX DENTAL MATERIALS INCORPORATED	Injectafil A2 Syringe with Extrusion Handle 106-A2-Kit	2018-07-06
GUDID 00850194007350 APEX DENTAL MATERIALS INCORPORATED	Interface Ceramic Etch and Silane 105-00	2018-07-06
GUDID 00850194007343 APEX DENTAL MATERIALS INCORPORATED	Seamfree Syringe 5 Pack with Tips 104-01-5pk	2018-07-06
GUDID 00850194007336 APEX DENTAL MATERIALS INCORPORATED	Seamfree Single Syringe with Tips 104-01	2018-07-06
GUDID 00850194007329 APEX DENTAL MATERIALS INCORPORATED	Seamfree Kit - Wetting Resin (3ml Bottle) 104-02	2018-07-06
GUDID 00850194007275 APEX DENTAL MATERIALS INCORPORATED	Superb Universal Adhesive Refill Kit 145-01	2018-07-06
GUDID 00850194007268 APEX DENTAL MATERIALS INCORPORATED	Superb Universal Adhesive Kit 145-00	2018-07-06
GUDID 00850194007251 APEX DENTAL MATERIALS INCORPORATED	Titan Flowable Composite Single Syringe Pack Shade White Opaque 103-02-WO	2018-07-06
GUDID 00850194007244 APEX DENTAL MATERIALS INCORPORATED	Titan Flowable Composite Single Syringe Pack Shade Translucent 103-02-T	2018-07-06
GUDID 00850194007237 APEX DENTAL MATERIALS INCORPORATED	Titan Flowable Composite Single Syringe Pack Shade B1 103-02-B1	2018-07-06
GUDID 00850194007220 APEX DENTAL MATERIALS INCORPORATED	Titan Flowable Composite Single Syringe Pack Shade A4 103-02-A4	2018-07-06
GUDID 00850194007213 APEX DENTAL MATERIALS INCORPORATED	Titan Flowable Composite Single Syringe Pack Shade A3.5 103-02-A3.5	2018-07-06
GUDID 00850194007206 APEX DENTAL MATERIALS INCORPORATED	Titan Flowable Composite Single Syringe Pack Shade A3 103-02-A3	2018-07-06
GUDID 00850194007190 APEX DENTAL MATERIALS INCORPORATED	Titan Flowable Composite Single Syringe Pack Shade A2 103-02-A2	2018-07-06
GUDID 00850194007183 APEX DENTAL MATERIALS INCORPORATED	Titan Flowable Composite Single Syringe Pack Shade A1 103-02-A1	2018-07-06
GUDID 00850194007176 APEX DENTAL MATERIALS INCORPORATED	Titan Flowable Composite 4 Pack Shade White Opaque 103-01-WO	2018-07-06
GUDID 00850194007169 APEX DENTAL MATERIALS INCORPORATED	Titan Flowable Composite 4 Pack Shade Translucent 103-01-T	2018-07-06
GUDID 00850194007145 APEX DENTAL MATERIALS INCORPORATED	Titan Flowable Composite 4 Pack Shade A4 103-01-A4	2018-07-06
GUDID 00850194007121 APEX DENTAL MATERIALS INCORPORATED	Titan Flowable Composite 4 Pack Shade A3 103-01-A3	2018-07-06
GUDID 00850194007114 APEX DENTAL MATERIALS INCORPORATED	Titan Flowable Composite 4 Pack Shade A2 103-01-A2	2018-07-06
GUDID 00850194007107 APEX DENTAL MATERIALS INCORPORATED	Titan Flowable Composite 4 Pack Shade A1 103-01-A1	2018-07-06
GUDID 00850194007084 APEX DENTAL MATERIALS INCORPORATED	Simplicity 2 Refill Bottle 100-62	2018-07-06
GUDID 00850194007077 APEX DENTAL MATERIALS INCORPORATED	Simplicity 1 Refill Bottle 100-61	2018-07-06
GUDID 00850194007060 APEX DENTAL MATERIALS INCORPORATED	Simplicity Refill Bottle Set 100-52	2018-07-06
GUDID 00850194007053 APEX DENTAL MATERIALS INCORPORATED	Simplicity Self Etch Dental Adhesive System 100-51	2018-07-06
GUDID 00850194007046 APEX DENTAL MATERIALS INCORPORATED	Surpass 3 Refill Bottle 101-04	2018-07-06
GUDID 00850194007039 APEX DENTAL MATERIALS INCORPORATED	Surpass 2 Refill Bottle 101-03	2018-07-06
GUDID 00850194007022 APEX DENTAL MATERIALS INCORPORATED	Surpass 1 Refill Bottle 101-02	2018-07-06
GUDID 00850194007015 APEX DENTAL MATERIALS INCORPORATED	Surpass Refill Kit 101-01	2018-07-06
GUDID 00850194007008 APEX DENTAL MATERIALS INCORPORATED	Surpass Self Etch Adhesive Kit 101-00	2018-07-06
PMN K161077 | KLE Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	Desensify	2017-11-27
PMN K161077 | KLE Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	DesensiMAX	2017-11-27
PMN K161077 | KLE Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	BondSaver	2017-11-27
PMN K161077 | KLE Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	BondSaver D	2017-11-27
PMN K161077 Apex Dental Materials, Inc	RnD TE And RnD SE	2017-03-17
PMN K984484 | EBF Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	Exquisite Restoration	2015-11-17
PMN K011431 | EMA Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	VistaCORE	2015-11-17
PMN K011431 | EMA Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	Anchor	2015-11-17
PMN K010547 | KLE Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	Vertex Sealant	2015-11-17
PMN K010547 | KLE Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	Armor	2015-11-17
PMN K131049 | KLE Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	ZR-P	2013-11-25
PMN K131043 | KLE Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	Vivid SureBond VII	2013-11-25
PMN K131043 | KLE Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	V-Force Solo	2013-11-25
PMN K131043 | KLE Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	Superb	2013-11-25
PMN K131043 | KLE Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	Regennex Universal Adhesive	2013-11-25
PMN K131043 | KLE Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	RE-GEN Universal Adhesive	2013-11-25
PMN K131043 APEX DENTAL MATERIALS, INC.	APEX UNIVERSAL ADHESIVE	2013-09-10
PMN K131049 APEX DENTAL MATERIALS, INC.	ZRP	2013-08-27
PMN K120620 | KLE Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	Regennex etchant / cleanser	2012-11-01
PMN K120620 | KLE Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	RE-GEN Cleanser	2012-11-01
PMN K120620 | KLE Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	Purify+	2012-11-01
PMN K120620 | KLE Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	Clean and Boost	2012-11-01
PMN K120620 | KLE Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	Clean & Boost Gel	2012-11-01
PMN K110859 | EBF Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	White Metal	2012-11-01
PMN K110859 | EBF Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	Aesthetic Metal	2012-11-01
PMN K110859 | EBD Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	White Metal	2012-11-01
PMN K110859 | EBD Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	Aesthetic Metal	2012-11-01
PMN K120620 APEX DENTAL MATERIALS, INC.	CLEAN AND BOOST	2012-05-31
PMN K110859 APEX DENTAL MATERIALS, INC.	METAL OPAQUER	2011-06-23
PMN K092539 | EBF Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	Seamless	2010-12-29
PMN K092539 | EBF Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	Seamfree	2010-12-29
PMN K091647 | KLE Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	VistaCORE	2010-12-29
PMN K091647 | KLE Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	RE-GEN Bulk Fill Composite and REsin Cement	2010-12-29
PMN K091647 | KLE Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	Injectafil	2010-12-29
PMN K091647 | EBF Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	VistaCORE	2010-12-29
PMN K091647 | EBF Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	RE-GEN Bulk Fill Composite and REsin Cement	2010-12-29
PMN K091647 | EBF Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	Injectafil	2010-12-29
PMN K092539 APEX DENTAL MATERIALS, INC.	SEAMFREE	2009-10-01
PMN K091647 APEX DENTAL MATERIALS, INC.	INJECTAFIL	2009-09-21
PMN K062157 | EBF Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	Titan	2008-12-09
PMN K062157 | EBF Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	RE-GEN Flowable Composite	2008-12-09
PMN K062157 | EBF Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	Conform	2008-12-09
PMN K061981 | KLE Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	Surpass	2008-12-09
PMN K061981 | KLE Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	RE-GEN Self Etch Adhesive	2008-12-09
PMN K053103 | KLE Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	Omni Etch	2006-10-27
PMN K053103 | KLE Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	INTERFACE	2006-10-27
PMN K020570 | KLE Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	V-Force Twin	2006-10-27
PMN K020570 | KLE Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	SIMPLICITY	2006-10-27
PMN K010849 | EBF Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	VERTEX	2006-10-27
PMN K010849 | EBF Apex Dental Materials, Inc [APEX DENTAL MATERIALS, INC.]	ICE	2006-10-27
PMN K062157 APEX DENTAL MATERIALS, INC.	CONFORM	2006-10-13
PMN K061981 APEX DENTAL MATERIALS, INC.	SURPASS	2006-07-31
PMN K053103 APEX DENTAL MATERIALS, INC.	INTERFACE	2006-02-01
PMN K020570 APEX DENTAL MATERIALS, INC.	SIMPLICITY	2002-04-24
PMN K010849 APEX DENTAL MATERIALS, INC.	VERTEX ETCHANT	2001-09-14
PMN K010547 APEX DENTAL MATERIALS, INC.	VERTEX SEALAND L/C ORTHODONTIC SEALANT	2001-08-16
PMN K010544 APEX DENTAL MATERIALS, INC.	VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE	2001-08-10

Related Finance Registrations

NCAGE Code	39PS7	APEX DENTAL MATERIALS INCORPORATED
CAGE Code	39PS7	APEX DENTAL MATERIALS, INCORPORATED
CAGE Code	7JUF4	APEX DENTAL MATERIALS INCORPORATED APEX DENTAL MATERIALS
S.A.M. Registration	7JUF4 [18651672]	APEX DENTAL MATERIALS INCORPORATED
DUNS	018651672	Apex Dental Materials Incorporated