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 2, 1992K910069SR-ISOSIT SPECTRA LINK SYSTEM
Ivoclar North America, Inc.
KLE
Dec 4, 1991K913965ESPE(R) -SIL
Espe GmbH (Us), DE
KLE
Dec 3, 1991K913946IMPERVA DUAL
Shofu Dental Corp.
KLE
Sep 6, 1991K911282PULPDENT ENAMEL BONDING AGENT
Pulpdent Corp.
KLE
Aug 20, 1991K912707CLEARFIL LINER BOND SYSTEM
Kuraray Co.
KLE
Jul 24, 1991K912256PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT
Lee Pharmaceuticals
KLE
May 15, 1991K911525TOKUSO LIGHT BOND
Tokuyama America, Inc.
KLE
Apr 29, 1991K910860ALL-BOND 2
Bisco, Inc.
KLE
Mar 29, 1991K910628ALL BOND LINER-F
Bisco, Inc.
KLE
Feb 26, 1991K905302DENTHESIVE
Kulzer, Inc.
KLE
Dec 7, 1990K904724CONQUEST DIRECT FILLING COMPOSITE (DFC)
Jeneric/Pentron, Inc.
KLE
Nov 1, 1990K904289PERTAC UNIVERSAL BOND
Espe GmbH (Us)
KLE
Aug 15, 1990K902744DEGUFILL (TM) BOND
Degussa AG
KLE
Aug 6, 1990K901871DEGUFILL (R) ADHESIVE
Degussa AG, DE
KLE
Aug 6, 1990K901870DEGUFILL (R) BOND
Degussa AG, DE
KLE
Jun 26, 1990K901913SYNTAC (DENTIN BONDING AGENT)
Ivoclar North America, Inc.
KLE
May 15, 1990K897009PALFIQUE LIGHT BONDING AGENT
Tokuyama America, Inc.
KLE
Apr 10, 1990K900558PERTAC BOND
Espe GmbH (Us)
KLE
Mar 14, 1990K897020ALL-BOND DENTIN BONDING SYSTEM
Bisco, Inc.
KLE
Feb 14, 1990K896659SILANE
Pulpdent Corp.
KLE
Feb 14, 1990K8966559.6% HYDROFLUORIC ACID GEL
Pulpdent Corp.
KLE
Feb 1, 1990K896382MODIFIED GLUMA BONDING SYSTEM
Heraeus Kulzer, Inc.
KLE
Dec 21, 1989K895750HEMA-PRIMER
Parkell
KLE
Oct 31, 1989K894315RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT
Lee Pharmaceuticals
KLE
Oct 24, 1989K894994DENTIN BONDING SYSTEM
Cosmedent, Inc.
KLE
Sep 19, 1989K894391PVS DUAL CURE VENEER BONDING KIT
Jelenko Co.
KLE
Jun 7, 1989K892003ABRAKADABRA - DENTAL ADHESIVE SYSTEM
Parkell
KLE
May 18, 1989K891455DENTIN PRIMER
Dentsply Intl.
KLE
Apr 12, 1989K884533SENSODYNE SEALANT DENTIN CONDITIONING SYSTEM
Block Drug Company, Inc.
KLE
Feb 13, 1989K885010TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING
Coe Laboratories, Inc.
KLE
Feb 13, 1989K884918PORCELAIN ETCHING GEL AND ETCHING GEL BARRIER
Parkell
KLE
Jan 19, 1989K884752KETAC-GLAZE
Espe GmbH (Us)
KLE
Dec 7, 1988K884137MIRAGE BOND
Chameleon Dental Products, Inc.
KLE
May 11, 1988K880684XR PRIMER
Kerr Corporation (Danbury)
KLE
Dec 29, 1987K874074TEMPORARY DISCLOSING SOLUTION
Dentsply Intl.
KLE
Nov 20, 1987K872959CLEARFIL PHOTO BOND
Kuraray Co.
KLE
Jul 2, 1987K871636CLEARFIL PORCELAIN BOND
Kuraray Co.
KLE
Sep 19, 1986K863522MODIFIED SELF-CURE BONDING AGENT
Dentsply Intl.
KLE
Sep 19, 1986K862829PANAGRAF
Panadent International, Inc.
KLE
Mar 25, 1986K860971DEN-MAT GOLD LINK (FORMERLY DEN-MAT METAL OPAQUER)
Den-Mat Corp.
KLE
Mar 25, 1986K860346KERR PORCELITE
Kerr Corporation (Danbury)
KLE
Jul 25, 1985K852660ETCH AND BOND
Dentsply Intl.
KLE
Apr 22, 1985K851056OPAQUER/BONDING AGENT
Dentsply Intl.
KLE
Oct 25, 1984K843025COMMAND ENAMEL-DENT DENTAL ADHESIVE
Kerr Corporation (Danbury)
KLE
Oct 25, 1984K843023KERR PORCELAIN REPAIR PRIMER
Kerr Corporation (Danbury)
KLE
Jul 12, 1984K842078JOHNSON & JOHNSON FLAVORED ETCHING GEL
Johnson & Johnson Professionals, Inc.
KLE
Jun 27, 1984K840726RESTODENT DENTIN BONDING AGENT
Lee Pharmaceuticals
KLE
May 22, 1984K841458NUMBER 20 R/L SYSTEM
Pentron Corp.
KLE
May 22, 1984K841457NUMBER 21 R/R SYSTEM
Pentron Corp.
KLE
Dec 29, 1983K833718ETCHING GEL
Johnson & Johnson Professionals, Inc.
KLE

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