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KLE

419 FDA 510(k) clearances · Product code

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RecordFirmDate
BEAUTIBOND MULTI (K110235)Shofu Dental Corp.2011-05-13
BEAUTIBOND MULTI PR PLUS (K110252)Shofu Dental Corp.2011-05-13
DMP SINGLE BONDING (K102254)Dmp, Ltd.2010-11-23
ALL-BOUND 3 (K102844)Bisco, Inc.2010-10-29
ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E (K101485)Bisco, Inc.2010-08-26
OPTIBOND XTR (K101423)Kerr Corporation2010-07-30
PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE) (K100752)Ultradent Products, Inc.2010-07-16
OPTIBOND SE (K100347)Kerr Corporation2010-04-30
AMERICAN DENTAL PRODUCTS SE BONDEASY (K093014)American Dental Products, Inc.2010-04-16
EXCITE F AND EXCITE DSC (K093744)Ivoclar Vivadent, Inc.2010-03-10
ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, MODELS 006-00029, 006-00030, 006-00044, 006-00045 (K092616)CAO Group, Inc.2009-10-21
PRIMER PLUS (K091705)Bisco, Inc.2009-08-28
ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079 (K091300)CAO Group, Inc.2009-07-23
ADHESE ONE F (K090941)Ivoclar Vivadent, Inc.2009-07-17
MONOBOND PLUS (K090826)Ivoclar Vivadent, Inc.2009-05-11
PRELUDE ONE (K090106)Danville Materials, Inc.2009-03-31
IBOND TOTAL ETCH (K083652)Heraeus Kulzer,GmbH2009-01-21
BEAUTIBOND (K082744)Shofu Dental Corp.2008-12-11
FUTURABOND M/FUTURABOND M SINGLE DOSE (K082753)Voco GmbH2008-11-24
G-BOND PLUS (K082768)GC America, Inc.2008-10-21
GENERATION 8 SE ADHESIVE (K072480)Pentron Clinical Technologies2007-11-21
RELIANCE S.E.P. (K071688)Reliance Orthodontic Products, Inc.2007-09-07
NANO-BOND II ADHESIVE SYSTEM (K071500)Pentron Clinical Technologies2007-08-10
UNO (K071131)3M Espe AG Dental Products2007-07-25
HERMES BOND 3 (K071260)3M Espe AG Dental Products2007-07-17
FL BOND II (K071452)Shofu Dental Corp.2007-07-09
FUTURABOND DC/SINGLE DOSE (K070723)Voco GmbH2007-06-07
SEA2 SELF ETCH ADHESIVE (K070956)3M Espe Dental Products2007-05-22
ADHESE ONE (K070646)Ivoclar Vivadent, Inc.2007-05-11
ASCENT UNIVERSAL ADHESIVE, MODEL 006-00028 (K070413)CAO Group, Inc.2007-04-26
TOKUYAMA BOND FORCE (K070215)Tokuyama Dental Corporation2007-03-30
TOTAL ETCH BONDING AGENT (K063444)Dmg USA, Inc.2007-03-20
XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE (K070538)Dentsply Intl.2007-03-14
ACE BOND SE (K063780)Bisco, Inc.2007-01-19
PEAK SE, MODEL 5135 (K063558)Ultradent Products, Inc.2006-12-14
PEAK BOND, MODEL 5133 (K063557)Ultradent Products, Inc.2006-12-12
HKBOND 2006 (K063062)Heraeus Kulzer, Inc.2006-12-01
ADHESIVE DC ACTIVATOR (K062713)Ivoclar Vivadent, Inc.2006-11-02
PREMIER SELF-ETCHING BOND ENHANCER (K061998)Premier Dental Products Co.2006-10-04
CLEARFIL DC BOND (K062382)Kuraray Medical, Inc.2006-09-27
BOSWORTH DENTIN RESIN (K061611)Harry J. Bosworth Co.2006-09-11
EXCEL BOND DC, MODEL 28-200100 (K060882)J. Morita USA, Inc.2006-09-01
SURPASS (K061981)Apex Dental Materials, Inc.2006-07-31
PORCELAIN PRIMER (K061322)J. Morita USA, Inc.2006-06-02
ADPER PROMPT, ADPER PROMPT L-POP (K060684)3M Espe AG Dental Products2006-04-24
OPTIBOND ALL-IN-ONE (K060469)Sybron Dental Specialties, Inc.2006-03-28
INTERFACE (K053103)Apex Dental Materials, Inc.2006-02-01
FUTURABOND NR SINGLE DOSE (K053392)Voco GmbH2005-12-15
VERSA-LINK PORCELAIN BONDING SYSTEM (K052699)Sultan Chemists, Inc.2005-11-16
MULTIPLE RESIN TOOTH BONDING AGENT (K052501)Cosmedent, Inc.2005-10-21
REVENEER CERAMIC REPAIR SYSTEM (K052189)Schutz-Dental GmbH2005-10-17
CLEARFIL TRI-S BOND SINGLE DOSE (K051796)Kuraray Medical Kurashiki Plant2005-08-09
ECLIPSE BONDING AGENT (K051707)Dentsply Intl.2005-07-15
XENO ADHESIVE WITH ACTIVATOR (K051463)Dentsply Intl.2005-07-12
SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 644092 (K051050)Schutz-Dental GmbH2005-06-29
IBOND NEXT GENERATION (K051006)Heraeus Kulzer,GmbH2005-06-07
ALL-IN-ONE (K050647)Bisco, Inc.2005-04-20
ADHESIVE 1 (K050331)Southern Dental Industries, Inc.2005-03-24
BOSWORTH BOND (K043170)Harry J. Bosworth Co.2005-02-25
PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM (K050386)Dentsply International2005-02-23
HERMES BOND 2 (K043043)3M Espe AG Dental Products2005-01-10
BC PLUS (K043562)Vericom Co., Ltd.2005-01-03
CLEARFIL TRI-S BOND (K042913)Kuraray Medical, Inc.2004-11-26
QUADRANT UNIT-1-BOND (K042806)Cavex Holland BV2004-11-24
S&C-SELF ETCH PR-BOND (K042614)S & C Polymer GmbH2004-11-22
ORAJEL ADVANCED TOOTH DESENSITIZER (K041680)Del Pharmaceuticals, Inc.2004-11-10
FUTURABOND NR (K042670)Voco GmbH2004-11-01
M.L. PRIMER (K040079)Shofu Dental Corp.2004-09-09
COMPOSITE/COMPOMER REPAIR KIT (K041960)Dmg USA, Inc.2004-08-30
G-BOND (K041471)GC America, Inc.2004-06-29
PRELUDE (K040952)Danville Materials, Inc.2004-06-29
XENO NM LIGHT CURED DENTAL ADHESIVE (K041343)Dentsply International2004-06-16
MODIFICATION TO ADPER PROMPT (K040857)3M Espe AG Dental Products2004-05-10
HERMES BOND (K033974)3M Espe AG Dental Products2004-02-06
CLEARFIL PROTECT BOND (K033938)Kuraray Medical, Inc.2004-01-29
ONE COAT SE BOND (K033760)Coltene/Whaledent, Inc.2004-01-23
EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT (K032953)Pulpdent Corporation2003-12-10
PERMAQUICK SE BONDING SYSTEM (K032626)Ultradent Products, Inc.2003-12-03
COMP. E (K032179)Parkell, Inc.2003-09-09
PULPDENT ETCH-RITE ROYALE (K031915)Pulpdent Corporation2003-08-05
OPTIBOND FL (K031444)Kerr Dental Materials Center2003-07-02
FINAL VARNISH LC (K030844)Voco GmbH2003-06-13
ETCHANT 40% (K030743)Confi-Dental Products Co.2003-05-09
CLEARFIL SILANE KIT (K024356)Kuraray Medical, Inc.2003-03-26
CLEARFIL SE BOND PLUS (K023842)Kuraray Medical, Inc.2003-02-11
XENO III DENTAL ADHESIVE (K023776)Dentsply Intl.2003-01-23
ADHESIVE 14 (K022973)Ab Ardent2002-11-22
PQ1 (K023042)Ultradent Products, Inc.2002-10-28
IBOND GLUMA INSIDE (K022612)Heraeus Kulzer, Inc.2002-10-28
CLEARFIL SA PRIMER (K021427)Kuraray Medical, Inc.2002-06-07
PULPDENT GLAZE II (K020514)Pulpdent Corporation2002-05-16
SIMPLICITY (K020570)Apex Dental Materials, Inc.2002-04-24
BOND-3 ADHESIVE (K020499)Jeneric/Pentron, Inc.2002-04-22
XR PRIMER 2 (K020303)Kerr Dental Materials Center2002-04-19
ADPER PROMPT (K020946)3M Espe AG Dental Products2002-04-04
TOUCH&BOND-PLUS (K020239)Parkell, Inc.2002-03-20
BOND-1 C & B (K013543)Jeneric/Pentron, Inc.2002-02-22
OPTIBOND SOLO PLUS 4 (K014027)Kerr Dental Materials Center2002-02-22
UNIFIL BOND (K013997)GC America, Inc.2002-02-20
DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1) (K013542)Jeneric/Pentron, Inc.2002-02-14
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