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333 FDA 510(k) clearances · Product code

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RecordFirmDate
QUARTZ SPLINT SYSTEM (UD, WOVEN, ROPE, MESH) QUARTZ SPINT RESIN QS FLOW (K122348)Recherches Techniques Dentaires (R.T.D.)2012-10-15
DEFLEX (K113608)Nuxen S.R.L.2012-04-10
DEFLEX ACRILATO (K113788)Nuxen S.R.L.2012-03-16
FOUNDATION DENTAL RESIN (K111709)Unix-Japan Co., Ltd.2011-11-18
ORTHO-JET CRYSTAL (K112397)Lang Dental Mfg. Co., Inc.2011-11-04
SOFRELINER TOUGH S (K112445)Tokuyama Dental Corporation2011-10-28
PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID (K111832)Heraeus Kulzer, LLC2011-09-29
JUELL SOFT CURE (K111178)Juell Dental2011-09-12
JUELL HARD CURE (K111177)Juell Dental2011-09-12
QUICK UP (K110440)Voco GmbH2011-05-04
PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID (K110037)Heraeus Kulzer, LLC2011-04-29
NEW STETIC ACRYLICS (K102874)New Stetic2011-03-28
VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS (K102640)Vertex-Dental B.V.2011-03-25
IVOBASE HYBRID, IVOBASE HIGH IMPACT (K103391)Ivoclar Vivadent, Inc.2011-02-17
VERTEX RAPID SIMPLIFIED (K102654)Vertex-Dental B.V.2010-12-03
FIBER FORCE (K102207)Synca Marketing, Inc.2010-11-23
GRANDTEC (K102347)Voco GmbH2010-10-29
JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MOD (K100653)Lang Dental Mfg. Co., Inc.2010-10-08
TOKUYAMA TISSUECARE (K081554)Tokuyama Dental Corporation2009-03-18
BIOCRYL X (K083479)Great Lakes Orthodontics, Ltd.2009-02-27
CFS FLEXIBLE (K081537)Comfort and Flexible Systems2009-01-22
PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440 (K082180)Angelus Industria DE Productos Odontologicos2008-12-17
MAJOR.REPAIR (K082153)Major Prodotti Dentari S.P.A.2008-11-25
LANG DENTAL ACRYLIC PRIMER (K081981)Lang Dental Mfg. Co., Inc.2008-11-17
MAJOR.BASE 20 (K081884)Major Prodotti Dentari S.P.A.2008-10-08
TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER (K081514)Lang Dental Mfg. Co., Inc.2008-09-22
POLYSTAR 79 DENTURE BASE RESIN (K072851)Cmp Industries, LLC2008-02-20
SMH FLEX S (K073040)Smh Biomaterial AG2007-12-13
FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD (K072479)Rapid Injection Systems Corp.2007-11-09
JET DENTURE REPAIR POWDER MEHARRY 100,454 GRAMS, JET DENTURE REPAIR PROFESSIONAL PACKAGE 100 GRAMS/118ML, 1220,30,23 (K072580)Lang Dental Mfg. Co., Inc.2007-11-05
FLEX-STAR V (K072402)Cmp Industries, LLC2007-10-19
ION DENTAL RESIN SYSTEM (K072713)Dentsply International, Inc.2007-10-12
TALON AND REVERE (K071245)Talon Acrylics, Inc.2007-08-02
COE SOFT (K070697)GC America, Inc.2007-03-29
COE COMFORT (K070698)GC America, Inc.2007-03-29
DURAFLEX (K063626)Cosmetic Dental Materials, Inc.2007-02-08
TENDER FIBER (K063170)Micerium S.P.A.2007-01-12
INFIBRA, MODEL 1200 (K061735)Global Dental Products, Inc.2006-09-08
ECLIPSE WAX REMOVER (K061580)Dentsply International2006-07-28
FLEXO DENTAL RESIN MATERIAL (K061501)Aci, Inc.2006-07-26
TCS UNBREAKABLE (K053060)Thermoplastic Comfort Systems, Inc.2006-07-20
SILKLINE SOFT RELINING KIT, MODEL 28-100100 (K060844)J. Morita USA, Inc.2006-06-06
MUCOHARD (K053516)Parkell, Inc.2006-01-26
BIOSPLINT SPLINTING RIBBON (K053328)Satelec2006-01-25
DENTAPLAST HOT, MODEL 16-XXX (K052780)Bredent-Products For the Dental Technician Laborat2005-12-21
FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 2000 (K052073)Schutz-Dental GmbH2005-10-26
NATURE-CRYL HI PLUS (K051358)GC America, Inc.2005-07-07
PALAIMPACT (K043504)Heraeus Kulzer, Inc.2005-01-28
VERSYO.DIRECT (K043295)Heraeus Kulzer, Inc.2005-01-05
TUF LINK SILICONE RELINER (K042931)Dentatus USA , Ltd.2004-12-08
METACRYL (K040881)Great Lakes Orthodontics, Ltd.2004-05-25
TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS (K034024)Bisco, Inc.2004-03-19
VARIFLEX (K033632)Great Lakes Orthodontics, Ltd.2004-01-21
TESCERA U-BAR AND BARRELS (K033472)Bisco, Inc.2004-01-15
VERSYO.BOND (K033629)Heraeus Kulzer, Inc.2003-12-22
IMPAK ACRYLIC REPAIR RESIN LIQUID (K033020)Cmp Industries, LLC2003-12-19
MODIFICATION TO TRUBYTE DENTURE BASE RESIN SYSTEM (K032892)Dentsply Intl.2003-09-26
DIAMOND D HIGH IMPACT DENTURE ACRYLIC (K032773)Mycone Dental Supply Co., Inc.2003-09-23
CARBON FIBER BRIDGE, MODEL 28757 (K031070)Nobel Biocare AB2003-07-03
UFI GEL HARD C (K030916)Voco GmbH2003-06-19
TOKUYAMA SOFRELINER TOUGH (K030663)Tokuyama Dental Corporation2003-05-29
EVERSTICK PERIO (K030072)Stick Tech , Ltd.2003-04-10
TOKUYAMA REBASE II (K022641)Tokuyama America, Inc.2002-10-02
SECURE SOFT (K021437)Imtec Corp.2002-07-19
SECURE RELINE/PICKUP MATERIAL (K021586)Imtec Corp.2002-06-14
AROMACRYL (K021121)Aromacryl, LLC2002-05-28
EVERSTICK ORTHO (K021126)Stick Tech , Ltd.2002-05-13
RIBBOND - TRIAXIAL (K013881)Ribbond, Inc.2002-01-25
BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060 (K012882)Thermoelastic Technologies, Inc.2001-11-14
EVERSTICKNET (K011799)Stick Tech , Ltd.2001-11-05
EVERSTICK (K011788)Stick Tech , Ltd.2001-11-05
DENTORIUM CONVERTIBLE ACRYLIC (K011820)Nats Corp.2001-09-05
HI-WAVE; POUR-PLUS (K011762)Denplus, Inc.2001-08-23
TRUBYTE DENTURE BASE RESIN SYSTEM (K011560)Dentsply Intl.2001-07-12
HARD RELINER (K011277)S & C Polymer GmbH2001-06-26
VERSYO.COM (K010800)Heraeus Kulzer, Inc.2001-05-31
STICK NET (K003334)Stick Tech , Ltd.2001-01-08
STICK (K003333)Stick Tech , Ltd.2001-01-04
JBC OPAQUE AND GLITTER (K002048)J.B.C and Co.2000-08-30
BIOSOFT RESIN (K001640)Biosoft International Corp.2000-06-23
SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156 (K001463)Davis Schottlander & Davis, Ltd.2000-06-16
EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL (K992176)St. George Technology, Inc.2000-02-10
UFI GEL HARD (K993827)Voco GmbH2000-01-20
ENIGMA HI-BASE DENTURE BASE MATERIAL (K993717)Davis Schottlander & Davis, Ltd.1999-12-22
MODIFICATION TO LINER II: SOFT RELINE LIQUID (K991687)Bosworth Co.1999-10-07
LUCITONE FRS FLEXIBEL DENTAL RESIN (K992956)Dentsply Intl.1999-10-06
HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400 (K992609)Kay See Dental Mfg. Co.1999-09-22
NIC TONE ACRYLIC RESINS (K991577)Manufacturera Dental Continental1999-09-22
IMPACT-PLUS, IMPACT-20, DP97, DP97-20, DP-POUR AND DP-REPAIR (K991996)Denplus, Inc.1999-09-08
ACRON MC MODIFICATION (K991774)GC America, Inc.1999-07-09
GC RELINE SOFT/EXTRA SOFT (K990736)GC America, Inc.1999-05-28
VITRON M (K990763)Espe Dental AG1999-05-25
VITRON H (K991220)Espe Dental AG1999-05-20
ORTHO-GLOW GLITTER (K990699)Harry J. Bosworth Co.1999-05-17
UNI-FLEX RESIN (K983461)Trans-Atlantic Dental1999-04-13
JELDENT MULTICRYL (K990056)J.F. Jelenko & Co., Inc.1999-03-25
THE.R.MO.FREE (K990448)Dentamax, Inc.1999-03-23
GC UNIFAST TRAD (K984365)GC America, Inc.1999-02-25
FUSICRYL (K984467)Micro Dental Laboratories1999-02-24
A-SOFT RELINER (K984483)S & C Polymer GmbH1999-02-18
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