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
Jan 11, 2000K993973FUJI II LC CAPSULE
GC America, Inc.
EBF
Jan 3, 2000K994251KETAC-MOLAR QUICK
Espe Dental AG, DE
EBF
Dec 22, 1999K993932SOLITAIRE 2
Heraeus Kulzer, Inc.
EBF
Dec 21, 1999K993716PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE
Harry J. Bosworth Co.
EBF
Dec 15, 1999K993602PRE-VISION FILL
Heraeus Kulzer, Inc.
EBF
Dec 13, 1999K993783TETRIC FLOW
Ivoclar North America, Inc.
EBF
Dec 6, 1999K993566PROMPTFLOW
Espe Dental AG, DE
EBF
Nov 24, 1999K992909HYTAC
Espe Dental AG, DE
EBF
Nov 10, 1999K993488LIGHT-CORE
Bisco, Inc.
EBF
Oct 27, 1999K993192ILLUSION
Bisco, Inc.
EBF
Oct 7, 1999K992966REFERENCE
Espe Dental AG, DE
EBF
Sep 22, 1999K992645SINFONY
Espe Dental AG, DE
EBF
Aug 31, 1999K992102LUMA LIGHT 2000 CURE LIGHT
Lumalite, Inc.
EBF
Aug 25, 1999K992248POST CEMENT HI-X
Bisco, Inc.
EBF
Aug 18, 1999K992118PRODIGY 4 TRANSLUCENT SHADES
Sybron Dental Specialties, Inc.
EBF
Aug 9, 1999K9919613M LVR SYSTEM
3M Company
EBF
Jul 9, 1999K991450ETCHING GEL
Silicon-Und Composite Spezialitaten GmbH, DE
EBF
Jun 21, 1999K991491FLC COMPOSITE
Harry J. Bosworth Co.
EBF
Jun 21, 1999K991488SELF CURE COMPOSITE
Harry J. Bosworth Co.
EBF
Jun 3, 1999K991442LC MICROFILL
S & C Polymer GmbH, DE
EBF
May 7, 1999K990756FLOW LINE
Heraeus Kulzer, Inc.
EBF
Apr 23, 1999K990982CAVIT LC
Espe Dental AG, DE
EBF
Apr 6, 1999K990898PRODIGY 4
Sybron Dental Specialties, Inc.
EBF
Apr 2, 1999K990314MULTI-CURE COMPOSITE CEMENT
Medental Intl.
EBF
Mar 9, 1999K990108LC FLOWFILL
S & C Polymer GmbH, DE
EBF
Mar 4, 1999K990315MONOPAQUE
Ivoclar North America, Inc.
EBF
Feb 9, 1999K984097DC-CORE
S & C Polymer GmbH, DE
EBF
Jan 20, 1999K984484LC MICROHYBRID
S & C Polymer GmbH, DE
EBF
Jan 13, 1999K984387R-30 AESTHETIC RESTORATIVE
Dentsply Intl.
EBF
Dec 22, 1998K984112ADVENT
Bisco, Inc.
EBF
Dec 16, 1998K984044QUADRANT POSTERIOR DENSE
Cavex Holland BV, NL
EBF
Dec 4, 1998K984043QUADRANT TOTAL ETCH
Cavex Holland BV, NL
EBF
Dec 4, 1998K984042QUADRANT CORE LC
Cavex Holland BV, NL
EBF
Dec 4, 1998K984041QUADRANT UNIVERSAL LC
Cavex Holland BV, NL
EBF
Nov 30, 1998K983751QUADRANT UNICHEM
Cavex Holland BV, NL
EBF
Nov 23, 1998K983549QUADRANT ANTERIOR SHINE
Cavex Holland BV, NL
EBF
Nov 18, 1998K983370PRODIGY- 3
Sybron Dental Specialties, Inc.
EBF
Nov 9, 1998K980800LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL
Cosmedent, Inc.
EBF
Oct 28, 1998K983091ELAN-2
Kerr Dental Materials Center
EBF
Oct 22, 1998K982692STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC
Sterngold/Implamed
EBF
Sep 22, 1998K982259CHROMA ZONE COLOR STAIN
Kuraray America, Inc.
EBF
Sep 15, 1998K982729RENEW
Bisco, Inc.
EBF
Sep 15, 1998K982318SPECTRUM 800 CURING UNIT
Dentsply Intl.
EBF
Sep 14, 1998K982191CHEMICAL CURE COMPOSITE WITH ENAMEL BOND
Medental Intl.
EBF
Sep 2, 1998K982645PYRAMID
Bisco, Inc.
EBF
Aug 18, 1998K982395DYTRACT FLOW RESTORATIVE
Dentsply Intl.
EBF
Aug 18, 1998K981948APOLLO 95E
Dental/Medical Diagnostic Systems, Inc.
EBF
Aug 10, 1998K982201ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE)
Foremost Dental Mfg., Inc.
EBF
Aug 10, 1998K982164ESTENIA
Kuraray America, Inc.
EBF
Aug 9, 1998K9816473M DENT II SYSTEM
3M Company
EBF

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