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
Mar 24, 1998K974906ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM
Coltene/Whaledent, Inc.
KLE
Mar 23, 1998K980539SOLOBOND M
Voco GmbH
KLE
Mar 23, 1998K973002HURRISEAL DENTIN DESENSITIZER
Cheng & Assoc., Inc.
KLE
Mar 3, 1998K974786PREPQUICK
Ultradent Products, Inc.
KLE
Feb 25, 1998K973285D/SENSE-T
Centrix, Inc.
KLE
Feb 4, 1998K974390GLUMA ONE BOND
Heraeus Kulzer, Inc.
KLE
Jan 29, 1998K974486CLEARFIL LINER BOND 2V
Kuraray America, Inc.
KLE
Jan 29, 1998K974283PQ 1
Ultradent Products, Inc.
KLE
Dec 17, 1997K974089ALLOY PRIMER
Kuraray America, Inc.
KLE
Dec 8, 1997K973092STAE
Southern Dental Industries, Inc.
KLE
Nov 14, 1997K973185AMERICAN DENTAL PRODUCTS HB-35 DESENSITIZER WITH FLUORIDE
American Dental Products, Inc.
KLE
Oct 7, 1997K973245TOKUSO REBASE MR. BOND
Tokuyama America, Inc.
KLE
Oct 2, 1997K9717332 BOND 2
Heraeus Kulzer, Inc.
KLE
Sep 29, 1997K972101SOLITAIRE
Heraeus Kulzer, Inc.
KLE
Sep 26, 1997K972858KERR NEXUS ONE BOTTLE ADHESIVE
Sybron Dental Specialties, Inc.
KLE
Sep 12, 1997K973388DENTIN CONDITIONING AND ADHESIVE (BOND 1)
Jeneric/Pentron, Inc.
KLE
Aug 29, 1997K972421EASY BOND
Parkell, Inc.
KLE
Aug 26, 1997K972594METALPRIMER II
GC America, Inc.
KLE
Jun 27, 1997K971121ENCORE BOND
Centrix, Inc.
KLE
May 6, 1997K970848SILOC SYSTEM
Heraeus Kulzer, Inc.
KLE
Apr 11, 1997K964867HYBRID RESIN COMPOSITE
Parkell, Inc.
KLE
Apr 2, 1997K964038CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG
Heraeus Kulzer, Inc.
KLE
Feb 14, 1997K965138DENTINSENSE B/C
Centrix, Inc.
KLE
Feb 5, 1997K964735DENTINSENSE
Centrix, Inc.
KLE
Jan 22, 1997K964525PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATOR
Dentsply Intl.
KLE
Jan 9, 1997K964133AMERICAN DENTAL PRODUCTS HG 35 DESENSITIZER WITH FLUORIDE
American Dental Products, Inc.
KLE
Nov 5, 1996K964140GLUMA CONDITIONER
Heraeus Kulzer, Inc.
KLE
Nov 5, 1996K964000BISFIL 2B
Bisco, Inc.
KLE
Oct 7, 1996K962812GLUMA DESENSITIZER/GLUMA 3 PRIMER
Heraeus Kulzer, Inc.
KLE
Sep 12, 1996K962428EBS (ESPE BONDING SYSTEM)
Espe GmbH & Co. Kg., DE
KLE
Aug 12, 1996K9627853M DENT SYSTEM
3M Company
KLE
Aug 1, 1996K962515KERR ADVANCED ADHESIVE
Kerr Dental Materials Center
KLE
Jul 18, 1996K962348PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT
Dentsply Intl.
KLE
Jul 18, 1996K960696PERMALUTE COMPOSITE LUTING/RESTORATIVE RESIN SYSTEM
Ultradent Products, Inc.
KLE
Jul 3, 1996K962277SELF CURE BONDING AGENT
Dent Zar, Inc.
KLE
Jun 11, 1996K961822WET-PREP
Bisco, Inc.
KLE
May 6, 1996K960697ULTRACID AND ULTRACID F DISINFECTING SOLUTION
Ultradent Products, Inc.
KLE
Apr 26, 1996K960823PRIME & BOND 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT
Dentsply Intl.
KLE
Mar 28, 1996K960365ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000)
Wallace A. Erickson & Co.
KLE
Mar 28, 1996K955328CONFI-BOND
Confi-Dental Products Co.
KLE
Mar 22, 1996K960879AMALGAMIBOND PLUS
Parkell, Inc.
KLE
Feb 8, 1996K955740GLUFLORMA
Midwest Orthodontic Mfg.
KLE
Dec 28, 1995K955279D-SENSE
Centrix, Inc.
KLE
Oct 30, 1995K954708SILANE PRIMER
Sybron Dental Specialties, Inc.
KLE
Oct 30, 1995K954133AMERICAN DENTAL PRODUCTS WETTING AGENT & DESENSITIZER
American Dental Products, Inc.
KLE
Oct 4, 1995K953613IMPERVA ENSURABOND
Shofu Dental Corp.
KLE
Oct 4, 1995K953612IMPERVA FLUOROBOND
Shofu Dental Corp.
KLE
Oct 3, 1995K953504MICROPRIME
Danville Engineering, Inc.
KLE
Sep 27, 1995K953405HEMA-BENZ
Health-Dent Intl., Inc.
KLE
Sep 27, 1995K953166FUJI BOND LC
GC America, Inc.
KLE

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