Medical Device Manufacturer · US , New York , NY

Kuraray Medical, Inc.

42 submissions · 42 cleared · Since 2001
42
Total
42
Cleared
0
Denied

Kuraray Medical, Inc. — FDA 510(k) Submissions

Kuraray Medical, Inc. has submitted 42 FDA 510(k) premarket notifications since 2001, of which 42 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Material, Tooth Shade, Resin, Agent, Tooth Bonding, Resin, Cement, Dental, Device, Caries Detection, Sealant, Pit And Fissure, And Conditioner . Use the specialty filter in the sidebar to narrow results.

42 devices
1–25 of 42
PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S
K120378 · EMA Cement, Dental · Dental
Mar 2012 52d
PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S
K120379 · EMA Cement, Dental · Dental
Mar 2012 52d
CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK
K111975 · KLE Agent, Tooth Bonding, Resin · Dental
Oct 2011 94d
CLEARFIL MAJETY POSTERIOR
K100328 · EBF Material, Tooth Shade, Resin · Dental
Mar 2010 29d
CLEARFIL MAJESTY POSTERIOR PLT
K092281 · EBF Material, Tooth Shade, Resin · Dental
Oct 2009 90d
CLEARFIL SA CEMENT
K081583 · EMA Cement, Dental · Dental
Jul 2008 53d
CLEARFIL MAJESTY POSTERIOR PLT
K071169 · EBF Material, Tooth Shade, Resin · Dental
Jun 2007 54d
CLEARFIL MAJESTY ESTHETIC PLT
K070325 · EBF Material, Tooth Shade, Resin · Dental
Mar 2007 44d
K-ETCHANT GEL
K062409 · EBF Material, Tooth Shade, Resin · Dental
Nov 2006 83d
CLEARFIL CERAMIC PRIMER
K061906 · EBF Material, Tooth Shade, Resin · Dental
Sep 2006 85d
CLEARFIL DC BOND
K062382 · KLE Agent, Tooth Bonding, Resin · Dental
Sep 2006 43d
CLEARFIL ESTHETIC CEMENT & DC BOND
K062410 · EMA Cement, Dental · Dental
Sep 2006 40d
CLEARFIL MAJESTY ESTHETIC
K061860 · EBF Material, Tooth Shade, Resin · Dental
Sep 2006 80d
CLEAFIL DC CORE AUTOMIX
K043177 · EBF Material, Tooth Shade, Resin · Dental
Dec 2004 31d
CLEARFIL TRI-S BOND
K042913 · KLE Agent, Tooth Bonding, Resin · Dental
Nov 2004 36d
CLEARFIL PHOTO CORE PLT
K033970 · EBF Material, Tooth Shade, Resin · Dental
Mar 2004 95d
CLEARFIL PROTECT BOND
K033938 · KLE Agent, Tooth Bonding, Resin · Dental
Jan 2004 41d
EPRICORD
K033267 · EBF Material, Tooth Shade, Resin · Dental
Dec 2003 74d
PANAVIA F 2.0
K032455 · EMA Cement, Dental · Dental
Nov 2003 88d
CLEARFIL SILANE KIT
K024356 · KLE Agent, Tooth Bonding, Resin · Dental
Mar 2003 86d
CLEARFIL SE BOND PLUS
K023842 · KLE Agent, Tooth Bonding, Resin · Dental
Feb 2003 85d
CLEARFIL AP-X PLT
K023002 · EBF Material, Tooth Shade, Resin · Dental
Oct 2002 46d
CLEARFIL AP-X PLT INTRO KIT
K022999 · EBF Material, Tooth Shade, Resin · Dental
Oct 2002 45d
CLEARFIL SA PRIMER
K021427 · KLE Agent, Tooth Bonding, Resin · Dental
Jun 2002 35d
CARIES DETECTOR
K012733 · LFC Device, Caries Detection · Dental
Sep 2001 31d
Filters
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