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
Sep 9, 1992K921602ULTRADENT PRODUCT TOOTH SURFACE DRYING AGENT
Ultradent Products, Inc.
EBF
Sep 9, 1992K921598ULTRADENT PRODUCT PIT & FISSURE SEALANT PROD LINE
Ultradent Products, Inc.
EBF
Sep 9, 1992K921409ENAMEL AND PORCELAIN ETCH PRODUCT LINE
Ultradent Products, Inc.
EBF
Sep 9, 1992K921407COMPOSITE AND PORCELAIN POLISHING PASTE PROD. LINE
Ultradent Products, Inc.
EBF
Sep 1, 1992K921174COMPOSITE RESIN CORE PASTE MATERIAL
Centrix, Inc.
EBF
Sep 1, 1992K920893LITE FILL II P
Shofu Dental Corp.
EBF
Sep 1, 1992K920892LITE FIL II A
Shofu Dental Corp.
EBF
Aug 20, 1992K922755PULPDENT HARD CORE
Pulpdent Corp.
EBF
Jul 15, 1992K922569TETRIC LIGHT-CURING COMPOSITE
Ivoclar North America, Inc.
EBF
Jun 16, 1992K921820RENAMEL ESTHETIC RESTORATIVE SYSTEM, MODIFICATION
Cosmedent, Inc.
EBF
May 11, 1992K921439BISCO CORE PASTE
Bisco, Inc.
EBF
Apr 29, 1992K920485PUPLDENT ETCH N PREP
Pulpdent Corp.
EBF
Apr 29, 1992K92048310% PHOSPHORIC ACID ETCHING GEL
Pulpdent Corp.
EBF
Apr 28, 1992K9204842.5% NITRIC ACID ETCHING GEL
Pulpdent Corp.
EBF
Apr 28, 1992K92048214% HYDROFLUORIC ACID ETCHING GEL
Pulpdent Corp.
EBF
Apr 21, 1992K915668BISCO CAVITY CLEANSER
Bisco, Inc.
EBF
Apr 21, 1992K913089WILDE LIGHT CURING COMPOSITE RESTORATIVE RESINS
Wilde-USA, Inc.
EBF
Mar 20, 1992K9204253M BRAND RESTORATIVE Z100
3M Company
EBF
Mar 19, 1992K920365TOOTH BONDING AGENT
Voco GmbH
EBF
Mar 11, 1992K914456DENTACOLOR(R) CRE-ACTIVE
Heraeus Kulzer, Inc.
EBF
Feb 3, 1992K915336TWINLOOK
Heraeus Kulzer, Inc.
EBF
Feb 3, 1992K913200GTI CLASP COVER
Gti, Inc.
EBF
Jan 31, 1992K915355ADS-GEL AND INSULATING-GEL
Heraeus Kulzer, Inc.
EBF
Jan 21, 1992K915335SILICOATER SYSTEM
Heraeus Kulzer, Inc.
EBF
Jan 14, 1992K913966SONO(R) -CEM
Espe GmbH (Us), DE
EBF
Oct 9, 1991K913947IMPERVA BOND
Shofu Dental Corp.
EBF
Oct 2, 1991K913100PALFIQUE INLAY
Tokuyama America, Inc.
EBF
Oct 2, 1991K913099PALFIQUE LITEPOSTERIOR
Tokuyama America, Inc.
EBF
Aug 23, 1991K912788CURAY SUPPORT
Scientific Pharmaceuticals, Inc.
EBF
Aug 20, 1991K912708CLEARFIL PHOTO ANTERIOR & LINER BOND SYSTEM
Kuraray Co.
EBF
Jun 7, 1991K912037DEGULUX LIGHT CURING UNIT
Degussa AG
EBF
Jun 3, 1991K910263CHARISMA
Kulzer, Inc.
EBF
May 31, 1991K904813VISIBLE LIGHT CURE COMPOSITE DENTAL RESTOR. MAT.
Alpha-Dent
EBF
May 29, 1991K911524PALFIQUE ESTELITE
Tokuyama America, Inc.
EBF
May 29, 1991K910627ALPHA-FIL, ALPHA-BASE & ALPHA-SILVER, MODIFICATION
Foremost Mfg., Inc.
EBF
Mar 29, 1991K905604VISIO-GEM ART-SYSTEM
Espe GmbH (Us)
EBF
Mar 29, 1991K904805TENTATIVE OPERATING NAME-JAZZ BAND
Franklin M. Din D.M.D., P.A.
EBF
Mar 15, 1991K905131DURAFILL COLOR VS
Kulzer, Inc.
EBF
Feb 26, 1991K904812COMPOSITE RESTORATIVE MATERIAL/RADIOPAQUE
Alpha-Dent
EBF
Feb 20, 1991K905476STOMADENT TM
Dentsply Intl.
EBF
Dec 17, 1990K905221SPECIAL BOND II
Ivoclar North America, Inc.
EBF
Dec 17, 1990K905220MONOBOND S
Ivoclar North America, Inc.
EBF
Dec 17, 1990K903481ALPHA-FILL, ALPHA-CEM, AND ALPHA-SILVER
Dental Foremost
EBF
Nov 13, 1990K904555DURAFILL FLOW
Kulzer, Inc.
EBF
Oct 22, 1990K901260CORADENT
Ivoclar North America, Inc.
EBF
Oct 9, 1990K903587HELIOLINK TRY-IN PASTES
Ivoclar North America, Inc.
EBF
Oct 9, 1990K902040ALTIS (RESIN, CROWN AND BRIDGES)
Pb2 Investment, Inc.
EBF
Oct 5, 1990K903551TEMPOREX
Scientific Pharmaceuticals, Inc.
EBF
Sep 6, 1990K902893TI-CORE (DENTAL COMPOSITE)
Medical Device Inspection Co., Inc.
EBF
Aug 29, 1990K902402HIGH SPEED NON-FIBER OPTIC SWIVEL HANDPIECE
Dentalez Group
EBF

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