Cosmedent Inc

FDA Filings

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

Cosmedent Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number1450653
FEI Number1450653
NameCOSMEDENT, INC.
Owner & OperatorCOSMEDENT, INC.
Contact Address401 NORTH MICHIGAN AVE. SUITE 2500
Chicago IL 60611 US
Official Correspondent
  • MICHAEL - O'MALLEY
  • x-312-6449586-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address4646 N. RAVENSWOOD AVE.
CHICAGO, IL 60640 US
Establishment TypeRepack or Relabel Medical Device



FDA Filings

Device
Company
DeviceDate
COSMEDENT, INC.
Matrix Band Primary Tooth 2021-07-27
Cosmedent, Inc
Renamel Bulkfill2021-06-24
COSMEDENT, INC.
Cosmedent 4092002021-06-14
COSMEDENT, INC.
FlexiWheel 2020-12-03
COSMEDENT, INC.
FlexiWheel 2020-12-03
COSMEDENT, INC.
FlexiWheel 2020-12-03
COSMEDENT, INC.
FlexiSaw 2020-05-06
COSMEDENT, INC.
FlexiDiamond Strips Narrow Coarse 2020-05-06
COSMEDENT, INC.
FlexiDiamond Strips Narrow Medium 2020-05-06
COSMEDENT, INC.
FlexiDiamond Strips Narrow Superfine 2020-05-06
COSMEDENT, INC.
FlexiDiamond Strips Wide Coarse 2020-05-06
COSMEDENT, INC.
FlexiDiamond Strips Wide Medium 2020-05-06
COSMEDENT, INC.
FlexiDiamond Strips Wide Superfine 2020-05-06
COSMEDENT, INC.
FlexiDiamond Strips Narrow Asst 2020-05-06
COSMEDENT, INC.
FlexiDiamond Strips Wide Asst 2020-05-06
COSMEDENT, INC.
FlexiDiamond Strips Sampler Asst 2020-05-06
COSMEDENT, INC.
FlexiStrips Regular Coarse/Medium 2020-05-06
COSMEDENT, INC.
FlexiStrips Regular Fine/Superfine 2020-05-06
COSMEDENT, INC.
FlexiStrips Narrow Coarse/Medium 2020-05-06
COSMEDENT, INC.
FlexiBrush Flame Shape 2020-05-06
COSMEDENT, INC.
FlexiBrush Cup Shape 2020-05-06
COSMEDENT, INC.
FlexiPoint Superfine 2020-05-06
COSMEDENT, INC.
FlexiPoint Medium 2020-05-06
COSMEDENT, INC.
FlexiCup Superfine 2020-05-06
COSMEDENT, INC.
FlexiCup Medium 2020-05-06
COSMEDENT, INC.
FlexiDisc Mini 5/8 Extrafine Garnet 2020-05-06
COSMEDENT, INC.
FlexiDisc Mini Assort Pack 1/2 5/8 2020-05-06
COSMEDENT, INC.
FlexiBuff Mini 3/8 2020-05-06
COSMEDENT, INC.
FlexiBuff Mini 1/2 2020-05-06
COSMEDENT, INC.
FlexiDisc Mini Assort Pack 5/8 2020-05-06
COSMEDENT, INC.
FlexiDisc Mini 5/8 Coarse Sand 2020-05-06
COSMEDENT, INC.
FlexiDisc Mini 5/8 Superfine 2020-05-06
COSMEDENT, INC.
FlexiDisc Mini 3/8 Superfine 2020-05-06
COSMEDENT, INC.
FlexiDisc Mini 1/2 Superfine 2020-05-06
COSMEDENT, INC.
FlexiDisc Mini 5/8 Fine 2020-05-06
COSMEDENT, INC.
FlexiDisc Mini 3/8 Fine 2020-05-06
COSMEDENT, INC.
FlexiDisc Mini 1/2 Fine 2020-05-06
COSMEDENT, INC.
FlexiDisc Mini 3/8 Medium 2020-05-06
COSMEDENT, INC.
FlexiDisc Mini 1/2 Coarse 2020-05-06
COSMEDENT, INC.
FlexiDisc Mini 5/8 Coarse 2020-05-06
COSMEDENT, INC.
FlexiDisc Mini 3/8 Coarse 2020-05-06
COSMEDENT, INC.
FlexiDisc Mini 1/2 Coarse 2020-05-06
COSMEDENT, INC.
FlexiDisc Mini Starter Kit 5/8 2020-05-06
COSMEDENT, INC.
FlexiDisc Mini Starter Kit 3/8 2020-05-06
COSMEDENT, INC.
FlexiDisc Mini Starter Kit 1/2 2020-05-06
COSMEDENT, INC.
FlexiDisc Mini All Purpose Kit 2020-05-06
COSMEDENT, INC.
FlexiBuff Regular 5/8 2020-05-06
COSMEDENT, INC.
FlexiDisc Regular 3/4 Extrafine Garnet 2020-05-06
COSMEDENT, INC.
FlexiDisc Regular 5/8 Coarse Sand 2020-05-06
COSMEDENT, INC.
FlexiDisc 5/8 Superfine 2020-05-06
COSMEDENT, INC.
FlexiDisc Regular 3/4 Superfine 2020-05-06
COSMEDENT, INC.
FlexiDisc 1/2 Superfine 2020-05-06
COSMEDENT, INC.
FlexiDisc 5/8 Fine 2020-05-06
COSMEDENT, INC.
FlexiDisc Regular 3/4 Fine 2020-05-06
COSMEDENT, INC.
FlexiDisc Regular 1/2 Fine 2020-05-06
COSMEDENT, INC.
FlexiDisc 5/8 Medium 2020-05-06
COSMEDENT, INC.
FlexiDisc Regular 3/4 Medium 2020-05-06
COSMEDENT, INC.
FlexiDisc Regular 1/2 Medium 2020-05-06
COSMEDENT, INC.
FlexiDisc Regular 5/8 Coarse 2020-05-06
COSMEDENT, INC.
FlexiDisc Regular 3/4 Coarse 2020-05-06
COSMEDENT, INC.
FlexiDisc 1/2 Coarse 2020-05-06
COSMEDENT, INC.
FlexiDisc Regular Starter Kit 2020-05-06
COSMEDENT, INC.
FlexiDisc Regular All Purpose Kit 2020-05-06
COSMEDENT, INC.
FlexiStrips Narrow Fine/Superfine 2020-05-06
COSMEDENT, INC.
Felt FlexiPoint 2020-05-06
COSMEDENT, INC.
FlexiBuff Mini 5/8 2020-05-06
COSMEDENT, INC.
Extra Oral Polisher Medium Disc 2020-03-23
COSMEDENT, INC.
Extra Oral Oral Polisher Medium Wheel 2020-03-23
COSMEDENT, INC.
Extra Oral Polisher Medium Point 2020-03-23
COSMEDENT, INC.
Extra Oral Polisher Superfine Disc 2020-03-23
COSMEDENT, INC.
Extra Oral Polisher Superfine Wheel 2020-03-23
COSMEDENT, INC.
Extra Oral Polisher Superfine Point 2020-03-23
COSMEDENT, INC.
All Ceramic Extra Oral Lithium Disilicate Cones 2020-03-23
COSMEDENT, INC.
All Ceramic Extra Oral Lithium Disilicate Wheels 2020-03-23
COSMEDENT, INC.
All Ceramic Extra Oral Zirconia Cones 2020-03-23
COSMEDENT, INC.
All Ceramic Extra Oral Zirconia Wheels 2020-03-23
COSMEDENT, INC.
All Ceramic Polishing Extra Oral Kit 2020-03-23
COSMEDENT, INC.
Intra Oral Polisher Medium Disc 2020-03-23
COSMEDENT, INC.
All Ceramic Polisher Intra Oral Medium Cup 2020-03-23
COSMEDENT, INC.
Intra Oral Polisher Medium Point 2020-03-23
COSMEDENT, INC.
Intra Oral Polisher Superfine Disc 2020-03-23
COSMEDENT, INC.
Intra Oral Polisher Superfine Cup 2020-03-23
COSMEDENT, INC.
All Ceramic Polisher Superfine Point 2020-03-23
COSMEDENT, INC.
All Ceramic Intra Oral Lithium Disilicate Cones 2020-03-23
COSMEDENT, INC.
All Ceramic Intra Oral Lithium Disilicate Wheels 2020-03-23
COSMEDENT, INC.
All Ceramic Intra Oral Zirconia Cones 2020-03-23
COSMEDENT, INC.
All Ceramic Intra Oral Zirconia Wheels 2020-03-23
COSMEDENT, INC.
All Ceramic Polishing Intra Oral Kit 2020-03-23
COSMEDENT, INC.
Nano/Microhybrid Diamond Polisher Superfine Wheel 2020-03-23
COSMEDENT, INC.
Nano/Microhybrid Diamond Polisher Superfine Point 2020-03-23
COSMEDENT, INC.
Nano/Microhybrid Diamond Polisher Superfine Cup 2020-03-23
COSMEDENT, INC.
Nano/Microhybrid Diamond Polisher Medium Wheel 2020-03-23
COSMEDENT, INC.
Nano/Microhybrid Diamond Polisher Medium Point 2020-03-23
COSMEDENT, INC.
Nano/Microhybrid Diamond Polisher Medium Cup 2020-03-23
COSMEDENT, INC.
Nano/Microhybrid Diamond Polisher Coarse Wheel 2020-03-23
COSMEDENT, INC.
Nano/MicrohybridDiamond Polisher Coarse Point 2020-03-23
COSMEDENT, INC.
Nano/Microhybrid Diamond Polisher Coarse Cup 2020-03-23
COSMEDENT, INC.
Nano/Hybrid Diamond Polishing Kit 2020-03-23
COSMEDENT, INC.
ResinKeeper 2020-02-25
COSMEDENT, INC.
Matrix Bands Pedo 2020-02-19
COSMEDENT, INC.
Matrix Bands Adult 2020-02-19
COSMEDENT, INC.
Instrument Tray2020-01-16
COSMEDENT, INC.
RSVP Impression Tray Upper2020-01-16
COSMEDENT, INC.
RSVP Impression Tray Lower2020-01-16
COSMEDENT, INC.
Compule Gun2020-01-14
COSMEDENT, INC.
Cosmedent Brushes2020-01-13
COSMEDENT, INC.
Matrix Bands2018-12-12
COSMEDENT, INC.
MirrorImage2018-07-30
COSMEDENT, INC.
Renamel Microfill2018-07-25
Cosmedent, Inc
Renamel Microfill2017-12-05
COSMEDENT, INC.
Renamel? NANO? +plus2017-03-29
Cosmedent, Inc
Renamel NANO +plus2017-02-24
COSMEDENT, INC.
Complete Primer/Unfilled Resin2012-11-06
COSMEDENT, INC.
Complete Unfilled Resin2012-11-06
COSMEDENT, INC.
Complete Dual-Cure Catalyst2012-11-06
COSMEDENT, INC.
Brush and Sculpt2010-01-21
COSMEDENT, INC.
COSMEDENT BRUSHABLE COMPOSITE2009-11-20
COSMEDENT, INC.
Porcelize2008-11-13
COSMEDENT, INC.
FlexiPoints2008-11-12
COSMEDENT, INC.
All Ceramic Polishers2008-11-12
COSMEDENT, INC.
Finishing Mandrels2008-11-05
COSMEDENT, INC.
Composite Pacement Instruments2008-11-05
COSMEDENT, INC.
FlexiStrip2008-11-05
COSMEDENT, INC.
FlexiCups2008-11-05
COSMEDENT, INC.
FlexiDisc2008-11-05
COSMEDENT, INC.
Kwik2008-05-15
COSMEDENT, INC.
CompositeEtch2008-05-15
COSMEDENT, INC.
da Vinci2008-05-15
COSMEDENT, INC.
Oxygone2008-05-15
COSMEDENT, INC.
Insure2008-05-15
COSMEDENT, INC.
PorcelEtch2008-05-15
COSMEDENT, INC.
GingaGuard2008-05-15
COSMEDENT, INC.
Impressiv2008-04-24
COSMEDENT, INC.
Renamel Posterior Body2008-03-19
COSMEDENT, INC.
Renamel Posterior Occlusal2008-03-19
COSMEDENT, INC.
RSVP Light Body2008-03-19
COSMEDENT, INC.
RSVP Heavy Body2008-03-19
COSMEDENT, INC.
Renamel Flowable Microhybrid2008-03-19
COSMEDENT, INC.
Renamel Flowable Microfill2008-03-19
COSMEDENT, INC.
Show-Off2008-03-19
COSMEDENT, INC.
E-Z Temp2008-03-19
COSMEDENT, INC.
Renamel? De-Mark?2008-03-19
COSMEDENT, INC.
Renamel Microhybrid2008-03-19
COSMEDENT, INC.
Prevue2008-03-19
COSMEDENT, INC.
Enamelize2008-03-19
COSMEDENT, INC.
Renamel Microfill2008-03-19
COSMEDENT, INC.
Renamel Gingafill2008-03-19
COSMEDENT, INC.
Creative Color2008-03-19
COSMEDENT, INC.
Renamel NANO2008-03-19
COSMEDENT, INC.
CosmeTemp2008-03-19
COSMEDENT, INC.
CosmeSeal2008-03-19
COSMEDENT, INC.
CosmeCore2008-03-19
COSMEDENT, INC.
NANO COMPOSITE2007-04-16
COSMEDENT, INC.
TEMPORARY CROWN & BRIDGE RESIN2006-05-16
COSMEDENT, INC.
Silanator2006-03-02
COSMEDENT, INC.
Desensitizer2006-03-02
COSMEDENT, INC.
MULTIPLE (TOOTH DESENSITIZER)2005-12-16
COSMEDENT, INC.
MULTIPLE RESIN TOOTH BONDING AGENT2005-10-21
COSMEDENT, INC.
COSMEDENT PIT & FISSURE SEALANT2004-12-01
COSMEDENT, INC.
MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL)2004-06-17
COSMEDENT, INC.
COSMEDENT CORE PASTE2004-06-03
COSMEDENT, INC.
PRIMOSPLINT SYSTEM2003-09-17
COSMEDENT, INC.
GINDA GUARD2002-02-14
COSMEDENT, INC.
RENAMEL PACK2000-01-18
COSMEDENT, INC.
RENAMEL SCULPT2000-01-18
COSMEDENT, INC.
LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL1998-11-09
COSMEDENT, INC.
HIGH VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL1998-10-28
COSMEDENT, INC.
FLOWABLE HYBRID1998-03-09
COSMEDENT, INC.
RENAMEL FLOWABLE COMPOSITE1998-02-10
COSMEDENT, INC.
E.Z. TEMEP, TEMPORARY FILLING MATERIAL1993-07-08
COSMEDENT, INC.
RENAMEL ESTHETIC RESTORATIVE SYSTEM, MODIFICATION1992-06-16
COSMEDENT, INC.
INSURE MATCH MATE PORCELAIN VENEER TRY-IN SYSTEM1990-01-10
COSMEDENT, INC.
DENTIN BONDING SYSTEM1989-10-24
COSMEDENT, INC.
INSURE PORCELAIN VENEER BONDING SYSTEM1987-12-29
COSMEDENT, INC.
RENAMELIZE POLISHING PASTE1986-08-12
COSMEDENT, INC.
RENAMEL ESTHETIC RESTORATIVE SYSTEM1986-03-13

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