ClearanceBrief
Panels › Dental › Product code KLE · Class 2

Agent, Tooth Bonding, Resin

Regulation 872.3200

9510(k)s in 12 months (421 all time)
0recalls in 12 months (20 all time)
20recalls that name a 510(k)
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Top companies in KLE

Company510(k)sRecalls
Ultradent Products, Inc.192
Dentsply Intl.200
Heraeus Kulzer, Inc.190
Bisco, Inc.180
Parkell160
Kerr Corporation410
Kuraray Medical, Inc.140
Shofu Dental Corp.130
GC America, Inc.110
Pulpdent Corp.110
Decided510(k)Device and applicantCode
Feb 20, 2002K013997UNIFIL BOND
GC America, Inc.
KLE
Feb 14, 2002K020050ENAMEL BONDING SYSTEM
Rite-Dent Manufacturing Corp.
KLE
Feb 14, 2002K013542DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1)
Jeneric/Pentron, Inc.
KLE
Jan 28, 2002K013584EXCITE SELF ETCH
Ivoclar Vivadent, Inc.
KLE
Jan 17, 2002K013519SIMPLE
Bisco, Inc.
KLE
Sep 20, 2001K012082OPTIBOND SOLO PLUS ACTIVATOR
Sybron Dental Specialties, Inc.
KLE
Sep 14, 2001K012734CLEARFIL NEW BOND
Kuraray Medical, Inc.
KLE
Sep 13, 2001K012730CLEARFIL PORCELAIN BOND ACTIVATOR
Kuraray Medical, Inc.
KLE
Sep 13, 2001K012729CLEARFIL REPAIR
Kuraray Medical, Inc.
KLE
Sep 10, 2001K012442MODIFICATION TO CLEARFIL SE BOND
Kuraray Medical, Inc.
KLE
Sep 5, 2001K012440MODIFICATION TO CLEARFIL LINER BOND 2V
Kuraray Medical, Inc.
KLE
Sep 4, 2001K012436MODIFICATION TO ALLOY PRIMER
Kuraray Medical, Inc.
KLE
Sep 4, 2001K012432MODIFICATION TO CLEARFIL PHOTO BOND
Kuraray Medical, Inc.
KLE
Aug 30, 2001K012322OPTIBOND 2
Sybron Dental Specialties, Inc.
KLE
Aug 16, 2001K010547VERTEX SEALAND L/C ORTHODONTIC SEALANT
Apex Dental Materials, Inc.
KLE
Jul 23, 2001K010415ISODAN
Specialites Septodont
KLE
Jun 27, 2001K011490MODIFICATION TO EXCITE
Ivoclar North America, Inc.
KLE
May 17, 2001K011167XSE
3M Company
KLE
Feb 6, 2001K003293EXCITE DSC
Ivoclar North America, Inc.
KLE
Nov 28, 2000K003011SELF ETCH BONDING PRIMER
Jeneric/Pentron, Inc.
KLE
Nov 15, 2000K003153SOLOBOND PLUS
Voco GmbH
KLE
Nov 8, 2000K002502CERAM-PRIME
S & C Polymer GmbH, DE
KLE
Aug 10, 2000K001914CLEARFIL REPAIR
Kuraray Company, Ltd.
KLE
Jul 7, 2000K001494MODIFICATION TO PROMPT L-POP
Espe Dental AG, DE
KLE
May 11, 2000K000189PQ1
Ultradent Products, Inc.
KLE
Apr 28, 2000K000954KERR GEL ETCHANT
Sybron Dental Specialties, Inc.
KLE
Mar 21, 2000K994359BOND 1 C & B
Jeneric/Pentron, Inc.
KLE
Feb 7, 2000K994302RESIN TOOTH BONDING AGENT
Parkell, Inc.
KLE
Feb 2, 2000K993917TOKUYAMA ONE-UP-BOND F
Tokuyama America, Inc.
KLE
Dec 13, 1999K993683PULPDENT UNO-DUO
Pulpdent Corp.
KLE
Nov 29, 1999K993013SURE BOND
Miradent Distributing Co., LLC
KLE
Nov 15, 1999K992838ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATE
Biomat Sciences, Inc.
KLE
Nov 9, 1999K992879ECUSIT COMPOSITE REPAIR
Dmg Hamburg
KLE
Oct 14, 1999K992985GLUMA COMFORT BOND
Heraeus Kulzer, Inc.
KLE
Oct 1, 1999K992292GLUMA COMFORT BOND + DESENSITIZER
Heraeus Kulzer, Inc.
KLE
Aug 16, 1999K992048MODIFICATION OF PROMPT L-POP
Espe Dental AG, DE
KLE
Jul 9, 1999K991808OPTIBOND SOLO PLUS 2
Sybron Dental Specialties, Inc.
KLE
Mar 19, 1999K990534EXCITE
Ivoclar North America, Inc.
KLE
Mar 8, 1999K990498OPTIBOND SOLO PLUS
Sybron Dental Specialties, Inc.
KLE
Feb 26, 1999K984503ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000
Wallace A. Erickson & Co.
KLE
Feb 25, 1999K990143GLUMA ONE BOND
Heraeus Kulzer, Inc.
KLE
Feb 4, 1999K990040CLEARFIL SE BOND
Kuraray Co.
KLE
Jan 8, 1999K984246PROMPT L-POP
Espe Dental AG, DE
KLE
Dec 16, 1998K983414EVERBOND
Espe Dental AG, DE
KLE
Nov 30, 1998K983668MODIFICATION OF PQ1
Ultradent Products, Inc.
KLE
Nov 18, 1998K983545QUADRANT UNIBOND
Cavex Holland BV, NL
KLE
Sep 21, 1998K982394PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM
Dentsply Intl.
KLE
Jul 22, 1998K982007TRUBYTE DENTURE BOND DENTURE BONDING AGENT
Dentsply Intl.
KLE
Jun 16, 1998K981514GC FUJI BOND LC
GC America, Inc.
KLE
Jun 16, 1998K981383ALLOYBOND
Southern Dental Industries, Inc.
KLE

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