Resin, Denture, Relining, Repairing, Rebasing

FDA product code EBI · 321 cleared devices

Class 2 Dental

Regulation: 21 CFR 872.3760
Review panel: DE
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1978-06-14 – 2026-08-27

EBI 2011-03-25

VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS

Applicant Vertex-Dental B.V.

K number K102640

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EBI 2011-02-17

IVOBASE HYBRID, IVOBASE HIGH IMPACT

Applicant Ivoclar Vivadent, Inc.

K number K103391

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EBI 2010-12-03

VERTEX RAPID SIMPLIFIED

Applicant Vertex-Dental B.V.

K number K102654

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EBI 2010-11-23

FIBER FORCE

Applicant Synca Marketing, Inc.

K number K102207

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EBI 2010-10-29

GRANDTEC

Applicant Voco GmbH

K number K102347

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EBI 2010-10-08

JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MOD

Applicant Lang Dental Mfg. Co., Inc.

K number K100653

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EBI 2009-03-18

TOKUYAMA TISSUECARE

Applicant Tokuyama Dental Corporation

K number K081554

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EBI 2009-02-27

BIOCRYL X

Applicant Great Lakes Orthodontics, Ltd.

K number K083479

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EBI 2009-01-22

CFS FLEXIBLE

Applicant Comfort and Flexible Systems

K number K081537

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EBI 2008-12-17

PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440

Applicant Angelus Industria DE Productos Odontologicos

K number K082180

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EBI 2008-11-25

MAJOR.REPAIR

Applicant Major Prodotti Dentari S.P.A.

K number K082153

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EBI 2008-11-17

LANG DENTAL ACRYLIC PRIMER

Applicant Lang Dental Mfg. Co., Inc.

K number K081981

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EBI 2008-10-08

MAJOR.BASE 20

Applicant Major Prodotti Dentari S.P.A.

K number K081884

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EBI 2008-09-22

TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER

Applicant Lang Dental Mfg. Co., Inc.

K number K081514

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EBI 2008-02-20

POLYSTAR 79 DENTURE BASE RESIN

Applicant Cmp Industries, LLC

K number K072851

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EBI 2007-12-13

SMH FLEX S

Applicant Smh Biomaterial AG

K number K073040

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EBI 2007-11-09

FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD

Applicant Rapid Injection Systems Corp.

K number K072479

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EBI 2007-11-05

JET DENTURE REPAIR POWDER MEHARRY 100,454 GRAMS, JET DENTURE REPAIR PROFESSIONAL PACKAGE 100 GRAMS/118ML, 1220,30,23

Applicant Lang Dental Mfg. Co., Inc.

K number K072580

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EBI 2007-10-19

FLEX-STAR V

Applicant Cmp Industries, LLC

K number K072402

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EBI 2007-10-12

ION DENTAL RESIN SYSTEM

Applicant Dentsply International, Inc.

K number K072713

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EBI 2007-08-02

TALON AND REVERE

Applicant Talon Acrylics, Inc.

K number K071245

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EBI 2007-03-29

COE COMFORT

Applicant GC America, Inc.

K number K070698

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EBI 2007-03-29

COE SOFT

Applicant GC America, Inc.

K number K070697

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EBI 2007-02-08

DURAFLEX

Applicant Cosmetic Dental Materials, Inc.

K number K063626

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EBI 2007-01-12

TENDER FIBER

Applicant Micerium S.P.A.

K number K063170

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EBI 2006-09-08

INFIBRA, MODEL 1200

Applicant Global Dental Products, Inc.

K number K061735

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EBI 2006-07-28

ECLIPSE WAX REMOVER

Applicant Dentsply International

K number K061580

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EBI 2006-07-26

FLEXO DENTAL RESIN MATERIAL

Applicant Aci, Inc.

K number K061501

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EBI 2006-07-20

TCS UNBREAKABLE

Applicant Thermoplastic Comfort Systems, Inc.

K number K053060

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EBI 2006-06-06

SILKLINE SOFT RELINING KIT, MODEL 28-100100

Applicant J. Morita USA, Inc.

K number K060844

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EBI 2006-01-26

MUCOHARD

Applicant Parkell, Inc.

K number K053516

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EBI 2006-01-25

BIOSPLINT SPLINTING RIBBON

Applicant Satelec

K number K053328

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EBI 2005-12-21

DENTAPLAST HOT, MODEL 16-XXX

Applicant Bredent-Products For the Dental Technician Laborat

K number K052780

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EBI 2005-10-26

FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 2000

Applicant Schutz-Dental GmbH

K number K052073

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EBI 2005-07-07

NATURE-CRYL HI PLUS

Applicant GC America, Inc.

K number K051358

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EBI 2005-01-28

PALAIMPACT

Applicant Heraeus Kulzer, Inc.

K number K043504

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EBI 2005-01-05

VERSYO.DIRECT

Applicant Heraeus Kulzer, Inc.

K number K043295

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EBI 2004-12-08

TUF LINK SILICONE RELINER

Applicant Dentatus USA , Ltd.

K number K042931

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EBI 2004-05-25

METACRYL

Applicant Great Lakes Orthodontics, Ltd.

K number K040881

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EBI 2004-03-19

TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS

Applicant Bisco, Inc.

K number K034024

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EBI 2004-01-21

VARIFLEX

Applicant Great Lakes Orthodontics, Ltd.

K number K033632

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EBI 2004-01-15

TESCERA U-BAR AND BARRELS

Applicant Bisco, Inc.

K number K033472

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EBI 2003-12-22

VERSYO.BOND

Applicant Heraeus Kulzer, Inc.

K number K033629

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EBI 2003-12-19

IMPAK ACRYLIC REPAIR RESIN LIQUID

Applicant Cmp Industries, LLC

K number K033020

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EBI 2003-09-26

MODIFICATION TO TRUBYTE DENTURE BASE RESIN SYSTEM

Applicant Dentsply Intl.

K number K032892

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EBI 2003-09-23

DIAMOND D HIGH IMPACT DENTURE ACRYLIC

Applicant Mycone Dental Supply Co., Inc.

K number K032773

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EBI 2003-07-03

CARBON FIBER BRIDGE, MODEL 28757

Applicant Nobel Biocare AB

K number K031070

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EBI 2003-06-19

UFI GEL HARD C

Applicant Voco GmbH

K number K030916

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EBI 2003-05-29

TOKUYAMA SOFRELINER TOUGH

Applicant Tokuyama Dental Corporation

K number K030663

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EBI 2003-04-10

EVERSTICK PERIO

Applicant Stick Tech , Ltd.

K number K030072

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EBI 2002-10-02

TOKUYAMA REBASE II

Applicant Tokuyama America, Inc.

K number K022641

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EBI 2002-07-19

SECURE SOFT

Applicant Imtec Corp.

K number K021437

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EBI 2002-06-14

SECURE RELINE/PICKUP MATERIAL

Applicant Imtec Corp.

K number K021586

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EBI 2002-05-28

AROMACRYL

Applicant Aromacryl, LLC

K number K021121

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EBI 2002-05-13

EVERSTICK ORTHO

Applicant Stick Tech , Ltd.

K number K021126

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EBI 2002-01-25

RIBBOND - TRIAXIAL

Applicant Ribbond, Inc.

K number K013881

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EBI 2001-11-14

BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060

Applicant Thermoelastic Technologies, Inc.

K number K012882

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EBI 2001-11-05

EVERSTICKNET

Applicant Stick Tech , Ltd.

K number K011799

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EBI 2001-11-05

EVERSTICK

Applicant Stick Tech , Ltd.

K number K011788

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EBI 2001-09-05

DENTORIUM CONVERTIBLE ACRYLIC

Applicant Nats Corp.

K number K011820

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EBI 2001-08-23

HI-WAVE; POUR-PLUS

Applicant Denplus, Inc.

K number K011762

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EBI 2001-07-12

TRUBYTE DENTURE BASE RESIN SYSTEM

Applicant Dentsply Intl.

K number K011560

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EBI 2001-06-26

HARD RELINER

Applicant S & C Polymer GmbH

K number K011277

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EBI 2001-05-31

VERSYO.COM

Applicant Heraeus Kulzer, Inc.

K number K010800

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EBI 2001-01-08

STICK NET

Applicant Stick Tech , Ltd.

K number K003334

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EBI 2001-01-04

STICK

Applicant Stick Tech , Ltd.

K number K003333

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EBI 2000-08-30

JBC OPAQUE AND GLITTER

Applicant J.B.C and Co.

K number K002048

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EBI 2000-06-23

BIOSOFT RESIN

Applicant Biosoft International Corp.

K number K001640

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EBI 2000-06-16

SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156

Applicant Davis Schottlander & Davis, Ltd.

K number K001463

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EBI 2000-02-10

EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL

Applicant St. George Technology, Inc.

K number K992176

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EBI 2000-01-20

UFI GEL HARD

Applicant Voco GmbH

K number K993827

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EBI 1999-12-22

ENIGMA HI-BASE DENTURE BASE MATERIAL

Applicant Davis Schottlander & Davis, Ltd.

K number K993717

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EBI 1999-10-07

MODIFICATION TO LINER II: SOFT RELINE LIQUID

Applicant Bosworth Co.

K number K991687

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EBI 1999-10-06

LUCITONE FRS FLEXIBEL DENTAL RESIN

Applicant Dentsply Intl.

K number K992956

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EBI 1999-09-22

HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400

Applicant Kay See Dental Mfg. Co.

K number K992609

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EBI 1999-09-22

NIC TONE ACRYLIC RESINS

Applicant Manufacturera Dental Continental

K number K991577

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EBI 1999-09-08

IMPACT-PLUS, IMPACT-20, DP97, DP97-20, DP-POUR AND DP-REPAIR

Applicant Denplus, Inc.

K number K991996

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EBI 1999-07-09

ACRON MC MODIFICATION

Applicant GC America, Inc.

K number K991774

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EBI 1999-05-28

GC RELINE SOFT/EXTRA SOFT

Applicant GC America, Inc.

K number K990736

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EBI 1999-05-25

VITRON M

Applicant Espe Dental AG

K number K990763

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EBI 1999-05-20

VITRON H

Applicant Espe Dental AG

K number K991220

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EBI 1999-05-17

ORTHO-GLOW GLITTER

Applicant Harry J. Bosworth Co.

K number K990699

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EBI 1999-04-13

UNI-FLEX RESIN

Applicant Trans-Atlantic Dental

K number K983461

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EBI 1999-03-25

JELDENT MULTICRYL

Applicant J.F. Jelenko & Co., Inc.

K number K990056

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EBI 1999-03-23

THE.R.MO.FREE

Applicant Dentamax, Inc.

K number K990448

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EBI 1999-02-25

GC UNIFAST TRAD

Applicant GC America, Inc.

K number K984365

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EBI 1999-02-24

FUSICRYL

Applicant Micro Dental Laboratories

K number K984467

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EBI 1999-02-18

A-SOFT RELINER

Applicant S & C Polymer GmbH

K number K984483

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EBI 1999-02-09

RESIN 4

Applicant Harry J. Bosworth Co.

K number K981862

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EBI 1999-01-08

STERNVANTAGE VARNISH LC, MODEL 221001

Applicant Sterngold/Implamed

K number K984341

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EBI 1999-01-07

PROTECH PLUS

Applicant Protech, Inc.

K number K983547

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EBI 1998-12-16

MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLIC

Applicant Mycone Dental Supply Co., Inc. (A/K/A Keystone Ind

K number K983876

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EBI 1998-11-13

MUCOPREN SOFT RELINING SYSTEM

Applicant Roydent Dental Products, Inc.

K number K983357

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EBI 1998-11-03

SILICONE SOFT RELINE

Applicant Harry J. Bosworth Co.

K number K981691

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EBI 1998-10-19

GC RELINE

Applicant GC America, Inc.

K number K982695

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EBI 1998-10-01

LINER 1:HARD RELINE LIQUID

Applicant Harry J. Bosworth Co.

K number K981861

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EBI 1998-08-24

TOKUYAMA SOFRELINER

Applicant Tokuyama America, Inc.

K number K982537

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EBI 1998-06-16

KERR HARD DENTURE RELINE MATERIAL

Applicant Sybron Dental Specialties, Inc.

K number K981448

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EBI 1998-04-30

PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15)

Applicant Kohler Medizintechnik GmbH & Co. KG

K number K980616

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EBI 1998-03-16

CSR

Applicant Parkell, Inc.

K number K974865

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