ClearanceBrief
Panels › Dental › Product code EBF · Class 2

Material, Tooth Shade, Resin

Regulation 872.3690

18510(k)s in 12 months (937 all time)
2recalls in 12 months (71 all time)
71recalls that name a 510(k)
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Top companies in EBF

Company510(k)sRecalls
Kerr Corp.943
Voco GmbH451
Sybron Dental Specialties287
Bisco, Inc.300
Pulpdent Corp.290
Scientific Pharmaceuticals, Inc.290
Dentsply Intl.280
Ivoclar North America, Inc.280
Shofu Dental Corp.270
GC America, Inc.240
Decided510(k)Device and applicantCode
Jul 31, 1998K982148PRODIGY 2
Sybron Dental Specialties, Inc.
EBF
Jul 30, 1998K981562SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANT
Sulzer Calcitek, Inc.
EBF
Jul 10, 1998K981813PERMACEM AUTOMIX LUTING CEMENT SYSTEM
Foremost Dental Mfg., Inc.
EBF
Jul 2, 1998K981264ARISTON PHC
Ivoclar USA, Inc.
EBF
May 19, 1998K980018CRISTOBAL
Newave Medical, Inc.
EBF
May 15, 1998K980793Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT
Rolence Enterprise Co. , Ltd., TW
EBF
May 15, 1998K980792CU-100A LIGHT CURE UNIT
Rolence Enterprise Co. , Ltd., TW
EBF
Apr 27, 1998K980058TOKUSO MAC BOND II
Tokuyama America, Inc.
EBF
Apr 27, 1998K980054PALFIQUE ESTELITE
Tokuyama America, Inc.
EBF
Mar 9, 1998K974465SYNERGY
Coltene/Whaledent, Inc.
EBF
Feb 24, 1998K980051PALFIQUE ESTELITE PASTE
Tokuyama America, Inc.
EBF
Feb 9, 1998K974483NTL-FLOW
Bisco, Inc.
EBF
Feb 9, 1998K973221COMPOSITE 168 RESTORATIVE SYSTEM
Dentsply Intl.
EBF
Feb 5, 1998K973235DYRACT AP RESTORATIVE
Dentsply Intl.
EBF
Feb 2, 1998K974413PERMAFLO
Ultradent Products, Inc.
EBF
Jan 30, 1998K974577COMPOGLASS FLOW
Ivoclar North America, Inc.
EBF
Jan 29, 1998K974282VITALESCENCE
Ultradent Products, Inc.
EBF
Jan 9, 1998K974105KERR COMPOMER
Sybron Dental Specialties, Inc.
EBF
Dec 22, 1997K973513SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUER
Espe GmbH & Co. Kg., DE
EBF
Dec 17, 1997K974131ALERT
Jeneric/Pentron, Inc.
EBF
Dec 8, 1997K973091WAVE
Southern Dental Industries, Inc.
EBF
Dec 8, 1997K973089FREEDOM
Southern Dental Industries, Inc.
EBF
Dec 4, 1997K973976EPIC-FLO
Parkell, Inc.
EBF
Nov 17, 1997K973257VERSAETCH
Centrix, Inc.
EBF
Oct 29, 1997K972292SOLIDEX
Shofu Dental Corp.
EBF
Oct 2, 1997K972892CAVIT-LC
Espe GmbH & Co. Kg., DE
EBF
Sep 12, 1997K971762BELLEGLASS HP ENAMEL REPAIR MATERIAL
Sybron Dental Specialties, Inc.
EBF
Sep 12, 1997K971594FLOW-RITE
Pulpdent Corp.
EBF
Jul 15, 1997K970683ZENTIH FLOWABLE COMPOSITE (MULTIPLE)
Foremost Dental Mfg., Inc.
EBF
Jun 24, 1997K971898PERMALUTE, TRY-IN PASTE
Ultradent Products, Inc.
EBF
Jun 3, 1997K971513COMPOGLASS F
Ivoclar North America, Inc.
EBF
May 29, 1997K971372VARIOLINK II
Ivoclar North America, Inc.
EBF
Apr 30, 1997K9705003M SUSTEL DENTAL SYSTEM
3M Company
EBF
Apr 16, 1997K970495FOUNDATION INDIRECT COMPOSITE RESIN
Sybron Dental Specialties, Inc.
EBF
Apr 16, 1997K970246EDTA CAVIT
Karolinski, SE
EBF
Mar 21, 1997K962376KREATIV KURING LIGHT SYSTEM
Kreativ, Inc.
EBF
Feb 10, 1997K964931WHITE CORE
Bisco, Inc.
EBF
Jan 31, 1997K965060ULTRA-ETCH STAT
Ultradent Products, Inc.
EBF
Jan 22, 1997K964285TETRIC CERAM
Ivoclar North America, Inc.
EBF
Jan 9, 1997K964179SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL SYRINGE TIPS
S.S. White Mfg., Ltd., GB
EBF
Dec 3, 1996K964578FIBREKOR
Jeneric/Pentron, Inc.
EBF
Nov 27, 1996K963805PRODIGY AC
Sybron Dental Specialties, Inc.
EBF
Nov 27, 1996K963735COJET SYSTEM
Espe GmbH & Co. Kg., DE
EBF
Oct 11, 1996K963652PULPDENT DESENSITIZER
Pulpdent Corp.
EBF
Oct 7, 1996K963311TEAM ETCH
Centrix, Inc.
EBF
Oct 7, 1996K962909DENTAL PREP WASH AND PREP DISINFECT
William J. Day
EBF
Sep 25, 1996K962878TARGIS SYSTEM
Ivoclar North America, Inc.
EBF
Sep 11, 1996K962442HYTAC APLITIP/HYTAC OSB
Espe GmbH & Co. Kg., DE
EBF
Sep 11, 1996K962440PERTAC II/PERTAC II APLITIP
Espe GmbH & Co. Kg., DE
EBF
Sep 3, 1996K962192SUNRISE CURING LAMP
Sunrise Technologies, Inc.
EBF

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