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
Dec 27, 1983K833473DENTIN BONDING AGENT
Johnson & Johnson Professionals, Inc.
KLE
Mar 17, 1983K830387MICRODAPT DENTAL RESTORATIVE BONDING
Johnson & Johnson Professionals, Inc.
KLE
Sep 7, 1982K822451AURAFILL* DENTAL RESTORATIVE BONDING AG.
Johnson & Johnson Professionals, Inc.
KLE
Jan 12, 1982K813180SCOTCHBOND DENTAL ADHESIVE
3M Company
KLE
Aug 31, 1981K812117PERMAGUM ADHESIVE
Espe-Premier Sales Co.
KLE
Aug 31, 1981K812116PERMAGUM
Espe-Premier Sales Co.
KLE
Mar 17, 1981K810407HYDROXYLATE ENAMEL BOND SYSTEM
Wallace A. Erickson & Co.
KLE
Feb 23, 1981K810265VISIO-BAND
Espe-Premier Sales Co.
KLE
Nov 24, 1980K802681HELIOBOND
Vivadent (Usa), Inc.
KLE
Nov 12, 1980K802333INSTANT BRIDGE
Scientific Pharmaceuticals, Inc.
KLE
May 28, 1980K801216DEN-MAT DENTIN BONDING AGENT
Den-Mat Corp.
KLE
May 20, 1980K801093PRISMA-BOND
Dentsply Intl.
KLE
Apr 10, 1980K800390ANT. & POST. RESTORATIVE POWDER LIQ.
American Dental Research
KLE
Apr 10, 1980K800389ANTERIOR & POST. RESTORATIVE PASTE SYS.
American Dental Research
KLE
Apr 30, 1979K790833VISIO-BOND
Espe GmbH (Us)
KLE
Jan 26, 1979K782080VENEER SYSTEM, MOSTIQUE LAMINATE
Caulk Co., Div. Dentsply
KLE
Aug 3, 1977K771328UVIOBOND
Espe GmbH (Us)
KLE
Aug 2, 1977K771326NIMETIC BONDING MATERIAL
Espe GmbH (Us)
KLE
Aug 2, 1977K771325NIMETIC ETCHING GEL
Espe GmbH (Us)
KLE
Aug 23, 1976K760400BONDING AGENT, VYTOL
L.D. Caulk Co.
KLE
Aug 3, 1976K760324BONDING AGENT, PRESTIGE
Lee Pharmaceuticals
KLE

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