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KLE

419 FDA 510(k) clearances · Product code

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RecordFirmDate
ENAMEL BONDING SYSTEM (K020050)Rite-Dent Manufacturing Corp.2002-02-14
EXCITE SELF ETCH (K013584)Ivoclar Vivadent, Inc.2002-01-28
SIMPLE (K013519)Bisco, Inc.2002-01-17
OPTIBOND SOLO PLUS ACTIVATOR (K012082)Sybron Dental Specialties, Inc.2001-09-20
CLEARFIL NEW BOND (K012734)Kuraray Medical, Inc.2001-09-14
CLEARFIL PORCELAIN BOND ACTIVATOR (K012730)Kuraray Medical, Inc.2001-09-13
CLEARFIL REPAIR (K012729)Kuraray Medical, Inc.2001-09-13
MODIFICATION TO CLEARFIL SE BOND (K012442)Kuraray Medical, Inc.2001-09-10
MODIFICATION TO CLEARFIL LINER BOND 2V (K012440)Kuraray Medical, Inc.2001-09-05
MODIFICATION TO CLEARFIL PHOTO BOND (K012432)Kuraray Medical, Inc.2001-09-04
MODIFICATION TO ALLOY PRIMER (K012436)Kuraray Medical, Inc.2001-09-04
OPTIBOND 2 (K012322)Sybron Dental Specialties, Inc.2001-08-30
VERTEX SEALAND L/C ORTHODONTIC SEALANT (K010547)Apex Dental Materials, Inc.2001-08-16
ISODAN (K010415)Specialites Septodont2001-07-23
MODIFICATION TO EXCITE (K011490)Ivoclar North America, Inc.2001-06-27
XSE (K011167)3M Company2001-05-17
EXCITE DSC (K003293)Ivoclar North America, Inc.2001-02-06
SELF ETCH BONDING PRIMER (K003011)Jeneric/Pentron, Inc.2000-11-28
SOLOBOND PLUS (K003153)Voco GmbH2000-11-15
CERAM-PRIME (K002502)S & C Polymer GmbH2000-11-08
CLEARFIL REPAIR (K001914)Kuraray Company, Ltd.2000-08-10
MODIFICATION TO PROMPT L-POP (K001494)Espe Dental AG2000-07-07
PQ1 (K000189)Ultradent Products, Inc.2000-05-11
KERR GEL ETCHANT (K000954)Sybron Dental Specialties, Inc.2000-04-28
BOND 1 C & B (K994359)Jeneric/Pentron, Inc.2000-03-21
RESIN TOOTH BONDING AGENT (K994302)Parkell, Inc.2000-02-07
TOKUYAMA ONE-UP-BOND F (K993917)Tokuyama America, Inc.2000-02-02
PULPDENT UNO-DUO (K993683)Pulpdent Corp.1999-12-13
SURE BOND (K993013)Miradent Distributing Co., LLC1999-11-29
ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATE (K992838)Biomat Sciences, Inc.1999-11-15
ECUSIT COMPOSITE REPAIR (K992879)Dmg Hamburg1999-11-09
GLUMA COMFORT BOND (K992985)Heraeus Kulzer, Inc.1999-10-14
GLUMA COMFORT BOND + DESENSITIZER (K992292)Heraeus Kulzer, Inc.1999-10-01
MODIFICATION OF PROMPT L-POP (K992048)Espe Dental AG1999-08-16
OPTIBOND SOLO PLUS 2 (K991808)Sybron Dental Specialties, Inc.1999-07-09
EXCITE (K990534)Ivoclar North America, Inc.1999-03-19
OPTIBOND SOLO PLUS (K990498)Sybron Dental Specialties, Inc.1999-03-08
ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000 (K984503)Wallace A. Erickson & Co.1999-02-26
GLUMA ONE BOND (K990143)Heraeus Kulzer, Inc.1999-02-25
CLEARFIL SE BOND (K990040)Kuraray Co.1999-02-04
PROMPT L-POP (K984246)Espe Dental AG1999-01-08
EVERBOND (K983414)Espe Dental AG1998-12-16
MODIFICATION OF PQ1 (K983668)Ultradent Products, Inc.1998-11-30
QUADRANT UNIBOND (K983545)Cavex Holland BV1998-11-18
PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM (K982394)Dentsply Intl.1998-09-21
TRUBYTE DENTURE BOND DENTURE BONDING AGENT (K982007)Dentsply Intl.1998-07-22
GC FUJI BOND LC (K981514)GC America, Inc.1998-06-16
ALLOYBOND (K981383)Southern Dental Industries, Inc.1998-06-16
ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM (K974906)Coltene/Whaledent, Inc.1998-03-24
HURRISEAL DENTIN DESENSITIZER (K973002)Cheng & Assoc., Inc.1998-03-23
SOLOBOND M (K980539)Voco GmbH1998-03-23
PREPQUICK (K974786)Ultradent Products, Inc.1998-03-03
D/SENSE-T (K973285)Centrix, Inc.1998-02-25
GLUMA ONE BOND (K974390)Heraeus Kulzer, Inc.1998-02-04
PQ 1 (K974283)Ultradent Products, Inc.1998-01-29
CLEARFIL LINER BOND 2V (K974486)Kuraray America, Inc.1998-01-29
ALLOY PRIMER (K974089)Kuraray America, Inc.1997-12-17
STAE (K973092)Southern Dental Industries, Inc.1997-12-08
AMERICAN DENTAL PRODUCTS HB-35 DESENSITIZER WITH FLUORIDE (K973185)American Dental Products, Inc.1997-11-14
TOKUSO REBASE MR. BOND (K973245)Tokuyama America, Inc.1997-10-07
2 BOND 2 (K971733)Heraeus Kulzer, Inc.1997-10-02
SOLITAIRE (K972101)Heraeus Kulzer, Inc.1997-09-29
KERR NEXUS ONE BOTTLE ADHESIVE (K972858)Sybron Dental Specialties, Inc.1997-09-26
DENTIN CONDITIONING AND ADHESIVE (BOND 1) (K973388)Jeneric/Pentron, Inc.1997-09-12
EASY BOND (K972421)Parkell, Inc.1997-08-29
METALPRIMER II (K972594)GC America, Inc.1997-08-26
ENCORE BOND (K971121)Centrix, Inc.1997-06-27
SILOC SYSTEM (K970848)Heraeus Kulzer, Inc.1997-05-06
HYBRID RESIN COMPOSITE (K964867)Parkell, Inc.1997-04-11
CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG (K964038)Heraeus Kulzer, Inc.1997-04-02
DENTINSENSE B/C (K965138)Centrix, Inc.1997-02-14
DENTINSENSE (K964735)Centrix, Inc.1997-02-05
PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATOR (K964525)Dentsply Intl.1997-01-22
AMERICAN DENTAL PRODUCTS HG 35 DESENSITIZER WITH FLUORIDE (K964133)American Dental Products, Inc.1997-01-09
GLUMA CONDITIONER (K964140)Heraeus Kulzer, Inc.1996-11-05
BISFIL 2B (K964000)Bisco, Inc.1996-11-05
GLUMA DESENSITIZER/GLUMA 3 PRIMER (K962812)Heraeus Kulzer, Inc.1996-10-07
EBS (ESPE BONDING SYSTEM) (K962428)Espe GmbH & Co. Kg.1996-09-12
3M DENT SYSTEM (K962785)3M Company1996-08-12
KERR ADVANCED ADHESIVE (K962515)Kerr Dental Materials Center1996-08-01
PERMALUTE COMPOSITE LUTING/RESTORATIVE RESIN SYSTEM (K960696)Ultradent Products, Inc.1996-07-18
PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT (K962348)Dentsply Intl.1996-07-18
SELF CURE BONDING AGENT (K962277)Dent Zar, Inc.1996-07-03
WET-PREP (K961822)Bisco, Inc.1996-06-11
ULTRACID AND ULTRACID F DISINFECTING SOLUTION (K960697)Ultradent Products, Inc.1996-05-06
PRIME & BOND 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT (K960823)Dentsply Intl.1996-04-26
CONFI-BOND (K955328)Confi-Dental Products Co.1996-03-28
ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000) (K960365)Wallace A. Erickson & Co.1996-03-28
AMALGAMIBOND PLUS (K960879)Parkell, Inc.1996-03-22
GLUFLORMA (K955740)Midwest Orthodontic Mfg.1996-02-08
D-SENSE (K955279)Centrix, Inc.1995-12-28
AMERICAN DENTAL PRODUCTS WETTING AGENT & DESENSITIZER (K954133)American Dental Products, Inc.1995-10-30
SILANE PRIMER (K954708)Sybron Dental Specialties, Inc.1995-10-30
IMPERVA FLUOROBOND (K953612)Shofu Dental Corp.1995-10-04
IMPERVA ENSURABOND (K953613)Shofu Dental Corp.1995-10-04
MICROPRIME (K953504)Danville Engineering, Inc.1995-10-03
HEMA-BENZ (K953405)Health-Dent Intl., Inc.1995-09-27
FUJI BOND LC (K953166)GC America, Inc.1995-09-27
MULTI-PRIME AKA/MONO-PRIME (K953476)Silicon-Und Composite Spezialitaten GmbH1995-09-22
REVOLUTION BOND (K953592)E&D Dental Products, Inc.1995-09-07
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