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)
Get daily alerts for KLESample briefCSV

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
Aug 1, 2011K111431B1P ADHESIVE
Pentron Clinical
KLE
May 19, 2011K110302ADHESIVE EXL-759
3M Espe AG, DE
KLE
May 13, 2011K110252BEAUTIBOND MULTI PR PLUS
Shofu Dental Corp.
KLE
May 13, 2011K110235BEAUTIBOND MULTI
Shofu Dental Corp.
KLE
Nov 23, 2010K102254DMP SINGLE BONDING
Dmp, Ltd., GR
KLE
Oct 29, 2010K102844ALL-BOUND 3
Bisco, Inc.
KLE
Aug 26, 2010K101485ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E
Bisco, Inc.
KLE
Jul 30, 2010K101423OPTIBOND XTR
Kerr Corporation
KLE
Jul 16, 2010K100752PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE)
Ultradent Products, Inc.
KLE
Apr 30, 2010K100347OPTIBOND SE
Kerr Corporation
KLE
Apr 16, 2010K093014AMERICAN DENTAL PRODUCTS SE BONDEASY
American Dental Products, Inc.
KLE
Mar 10, 2010K093744EXCITE F AND EXCITE DSC
Ivoclar Vivadent, Inc.
KLE
Oct 21, 2009K092616ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, MODELS 006-00029, 006-00030, 006-00044, 006-00045
CAO Group, Inc.
KLE
Aug 28, 2009K091705PRIMER PLUS
Bisco, Inc.
KLE
Jul 23, 2009K091300ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079
CAO Group, Inc.
KLE
Jul 17, 2009K090941ADHESE ONE F
Ivoclar Vivadent, Inc.
KLE
May 11, 2009K090826MONOBOND PLUS
Ivoclar Vivadent, Inc.
KLE
Mar 31, 2009K090106PRELUDE ONE
Danville Materials, Inc.
KLE
Jan 21, 2009K083652IBOND TOTAL ETCH
Heraeus Kulzer,GmbH
KLE
Dec 11, 2008K082744BEAUTIBOND
Shofu Dental Corp.
KLE
Nov 24, 2008K082753FUTURABOND M/FUTURABOND M SINGLE DOSE
Voco GmbH, DE
KLE
Oct 21, 2008K082768G-BOND PLUS
GC America, Inc.
KLE
Nov 21, 2007K072480GENERATION 8 SE ADHESIVE
Pentron Clinical Technologies
KLE
Sep 7, 2007K071688RELIANCE S.E.P.
Reliance Orthodontic Products, Inc.
KLE
Aug 10, 2007K071500NANO-BOND II ADHESIVE SYSTEM
Pentron Clinical Technologies
KLE
Jul 25, 2007K071131UNO
3M Espe AG Dental Products, DE
KLE
Jul 17, 2007K071260HERMES BOND 3
3M Espe AG Dental Products, DE
KLE
Jul 9, 2007K071452FL BOND II
Shofu Dental Corp.
KLE
Jun 7, 2007K070723FUTURABOND DC/SINGLE DOSE
Voco GmbH, DE
KLE
May 22, 2007K070956SEA2 SELF ETCH ADHESIVE
3M Espe Dental Products
KLE
May 11, 2007K070646ADHESE ONE
Ivoclar Vivadent, Inc.
KLE
Apr 26, 2007K070413ASCENT UNIVERSAL ADHESIVE, MODEL 006-00028
CAO Group, Inc.
KLE
Mar 30, 2007K070215TOKUYAMA BOND FORCE
Tokuyama Dental Corporation
KLE
Mar 20, 2007K063444TOTAL ETCH BONDING AGENT
Dmg USA, Inc.
KLE
Mar 14, 2007K070538XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE
Dentsply Intl.
KLE
Jan 19, 2007K063780ACE BOND SE
Bisco, Inc.
KLE
Dec 14, 2006K063558PEAK SE, MODEL 5135
Ultradent Products, Inc.
KLE
Dec 12, 2006K063557PEAK BOND, MODEL 5133
Ultradent Products, Inc.
KLE
Dec 1, 2006K063062HKBOND 2006
Heraeus Kulzer, Inc.
KLE
Nov 2, 2006K062713ADHESIVE DC ACTIVATOR
Ivoclar Vivadent, Inc.
KLE
Oct 4, 2006K061998PREMIER SELF-ETCHING BOND ENHANCER
Premier Dental Products Co.
KLE
Sep 27, 2006K062382CLEARFIL DC BOND
Kuraray Medical, Inc.
KLE
Sep 11, 2006K061611BOSWORTH DENTIN RESIN
Harry J. Bosworth Co.
KLE
Sep 1, 2006K060882EXCEL BOND DC, MODEL 28-200100
J. Morita USA, Inc.
KLE
Jul 31, 2006K061981SURPASS
Apex Dental Materials, Inc.
KLE
Jun 2, 2006K061322PORCELAIN PRIMER
J. Morita USA, Inc.
KLE
Apr 24, 2006K060684ADPER PROMPT, ADPER PROMPT L-POP
3M Espe AG Dental Products, DE
KLE
Mar 28, 2006K060469OPTIBOND ALL-IN-ONE
Sybron Dental Specialties, Inc.
KLE
Feb 1, 2006K053103INTERFACE
Apex Dental Materials, Inc.
KLE
Dec 15, 2005K053392FUTURABOND NR SINGLE DOSE
Voco GmbH, DE
KLE

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.