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 1998-03-11

BRUXTRAK MATERIAL

Applicant Bruxcare, LLC

K number K974160

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EBI 1998-02-24

JET ACRYLIC LIQUID-MONOMER, ORTHO JET POWDER-POLYMER, PLASTICIZED METHACRYLATE HOMOPOLYMER, METHACRYLATE COPOLYMER, METR

Applicant J.B.C and Co.

K number K974727

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EBI 1998-02-10

UFI GEL C

Applicant Voco GmbH

K number K974772

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EBI 1998-02-10

MASKY

Applicant Pressing DI Monticelli Rag. Stefano

K number K973542

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EBI 1997-11-13

LANG DENTAL RESIN A97 FIBRED PINK

Applicant Lang Dental Mfg. Co., Inc.

K number K972553

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EBI 1997-09-16

LIQCRYLIC PRO DENTAL RESIN

Applicant Dentsply Intl.

K number K972573

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EBI 1997-07-21

DINABASE (TM)

Applicant Sultan Chemists, Inc.

K number K971138

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EBI 1997-05-14

MYERSON'S ECONOMY DENTURE BASE MATERIAL

Applicant Austenal, Inc.

K number K970522

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EBI 1996-12-06

TRUBYTE SOFT RELINE SYSTEM

Applicant Dentsply Intl.

K number K964040

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EBI 1996-12-04

SOFT DENTURE REBASING RESIN

Applicant Sybron Dental Specialties, Inc.

K number K963736

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EBI 1996-10-29

GC BASELINE

Applicant GC America, Inc.

K number K963144

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EBI 1996-08-07

V.R.S. DENTURE RESIN MATERIAL

Applicant Vident

K number K962333

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EBI 1996-07-22

FIBER-SPLINT ML MULTILAYER

Applicant Polydentia USA

K number K962374

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EBI 1996-06-26

QUICKSPLINT

Applicant Heraeus Kulzer, Inc.

K number K961995

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EBI 1996-05-17

BOSWORTH LIQUID RESIN II

Applicant Harry J. Bosworth Co.

K number K961200

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EBI 1996-01-18

TOKUYAMA SOFT RELINING

Applicant Tokuyama America, Inc.

K number K953589

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EBI 1995-12-28

AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELINER

Applicant American Dental Products, Inc.

K number K954637

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EBI 1995-11-29

MYERSON IR DENTURE BASE

Applicant Austenal, Inc.

K number K954810

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EBI 1995-10-30

CONNECT

Applicant Sybron Dental Specialties, Inc.

K number K954689

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EBI 1995-10-02

PALASPLINT

Applicant Heraeus Kulzer, Inc.

K number K953743

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EBI 1995-09-27

PROP. CONQUEST C&B VLC GLAZE/SEALANT

Applicant Jeneric/Pentron, Inc.

K number K953381

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EBI 1995-08-28

BOSWORTH RESIN II

Applicant Bosworth Co.

K number K953119

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EBI 1995-07-07

PRECISE DENTURE BASE RESIN

Applicant Dentsply Intl.

K number K952351

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EBI 1995-03-02

SEALDENT

Applicant Scientific Pharmaceuticals, Inc.

K number K944466

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EBI 1995-02-27

PRO-CRYLIC RESIN, TECHNICOLOR PRE-MIX MONOMER

Applicant Professional Positioners, Inc.

K number K943905

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EBI 1995-02-16

HARRY J. BOSWORTH RESIN I.

Applicant Harry J. Bosworth Co.

K number K946317

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EBI 1995-02-02

EXCEL-P FORMULA AUTO-CURE DENTURE BASE

Applicant St. George Technology, Inc.

K number K945711

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EBI 1994-12-20

PROSTHOFLEX

Applicant Knopf Assoc, Inc.

K number K942562

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EBI 1994-05-27

ORTHO-JET ACRYLIC RESIN - SPARKLE

Applicant Lang Dental Mfg. Co., Inc.

K number K941925

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EBI 1994-05-04

COE-SOFT LC

Applicant GC America, Inc.

K number K940565

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EBI 1994-01-26

KOOLINER II

Applicant GC America, Inc.

K number K935261

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EBI 1994-01-21

REBARON LC

Applicant GC America, Inc.

K number K930939

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EBI 1994-01-18

EXCEL FORMULA HEAT-AUTO CURE DENT BASE/REPAIR/ORTHO

Applicant St. George Technology, Inc.

K number K934019

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EBI 1994-01-05

MYERSON'S PERMASOFT SOFT RELINE MATERIAL

Applicant Austenal, Inc.

K number K933468

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EBI 1993-12-08

ALPHA-DENT TISSUE CONDITIONER AND TEMPORARY RELINER

Applicant Wallace A. Erickson & Co.

K number K934248

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EBI 1993-12-06

PERMASOFT SOFT RELINE MATERIAL BY NU-DENT, INC.

Applicant Nu-Dent, Inc.

K number K933831

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EBI 1993-03-31

DUAL CURE RELINE MATERIAL

Applicant Dentsply Intl.

K number K926406

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EBI 1993-03-31

PERMAFLEX PERMANENT SOFT DENTURE RELINER

Applicant Protech Professional Products, Inc.

K number K925062

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EBI 1993-01-11

SOFT DENTURE RELINE MATERIAL ELASTOLINE

Applicant Great Lakes Orthodontics, Ltd.

K number K925275

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EBI 1992-11-04

PALABOND

Applicant Heraeus Kulzer, Inc.

K number K924422

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EBI 1992-09-16

PALADUR

Applicant Heraeus Kulzer, Inc.

K number K915898

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EBI 1992-03-25

CONVERBASE

Applicant Wilde-USA, Inc.

K number K912990

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EBI 1992-03-20

WIL-O-DONT ORTHODONTIC MATERIAL/WIL-O-LUX

Applicant Wilde-USA, Inc.

K number K920557

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EBI 1992-02-03

WILDE DENTURE RESINS

Applicant Wilde-USA, Inc.

K number K912993

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EBI 1992-01-31

SR-IVOCAP PLUS

Applicant Ivoclar North America, Inc.

K number K915377

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EBI 1991-12-19

WILDE AUXILIARIES

Applicant Wilde-USA, Inc.

K number K912991

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EBI 1991-10-17

PROBASE HOT AND PROBASE COLD

Applicant Ivoclar North America, Inc.

K number K913655

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EBI 1991-10-09

MODERN MATERIALS ORTHODONTIC RESIN

Applicant Heraeus Kulzer, Inc.

K number K913699

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EBI 1991-10-09

ACCELAR 20 ADVANCE RAPID CURE REPAIR MATERIAL

Applicant Heraeus Kulzer, Inc.

K number K913698

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EBI 1991-10-07

RIBBOND(TM)

Applicant Ribbond, Inc.

K number K913040

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EBI 1991-07-11

COMFOR-DENT DENTURE LINER

Applicant Comfort Acrylics Co.

K number K910795

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EBI 1991-06-06

MELIODENT, DENTURE RESIN

Applicant Heraeus Kulzer, Inc.

K number K910465

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EBI 1991-04-29

NEW TRIAD TRANSHEET DENTURE BASE MATERIAL

Applicant Dentsply Intl.

K number K905702

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EBI 1990-10-04

FLEXOR (DENTURE ACRYLIC RELINE MATERIAL)

Applicant Cmp Industries, LLC

K number K902972

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EBI 1990-07-27

PALAPRESS(R) VARIO RESIN

Applicant Kulzer, Inc.

K number K902115

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EBI 1990-06-26

NEW PER-FIT(R) IMPROVED

Applicant Dental Product Co.

K number K901621

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EBI 1990-06-22

PALADON(R) 65

Applicant Kulzer, Inc.

K number K901789

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EBI 1990-05-15

COMFORT ACRYLICS PLIABLE DENTURE LINERS & SPLINTS

Applicant Comfort Acrylics Co.

K number K900799

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EBI 1990-05-15

NOVUS BONDING AGENT

Applicant The Hygenic Corp.

K number K900301

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EBI 1990-05-15

TOKUSO REBASE

Applicant Tokuyama America, Inc.

K number K896981

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EBI 1990-05-15

PALFIQUE LIGHT LINER

Applicant Tokuyama America, Inc.

K number K896980

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EBI 1990-04-16

SR-IVOSEAL

Applicant Ivoclar North America, Inc.

K number K896139

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EBI 1990-04-16

SR-IVOCAP

Applicant Ivoclar North America, Inc.

K number K896130

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EBI 1990-02-22

PRIMER-P ADHESIVE AGENT

Applicant Parkell

K number K896719

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EBI 1989-12-21

ORTHO-KEV APPLIANCE REINFORCING SYSTEM

Applicant American Orthodontics

K number K895714

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EBI 1989-12-18

LITELINE VLC SOFT RELINE

Applicant Dentsply Intl.

K number K895742

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EBI 1989-10-24

CURAY-FORM

Applicant Scientific Pharmaceuticals, Inc.

K number K895222

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EBI 1989-10-17

RELIANCE LIGHT CURE RETAINER ACRYLIC

Applicant Reliance Orthodontic Products, Inc.

K number K894564

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EBI 1989-06-16

PALASEAL(R)

Applicant Kulzer, Inc.

K number K892452

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EBI 1989-05-01

DENTURE RESIN

Applicant G-C Intl. Corp.

K number K890830

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EBI 1989-01-30

PERMASEAL AND DENTURE SEAL

Applicant American Mfg., Inc.

K number K884865

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EBI 1989-01-27

DANSU PERMANENT CHAIR SOFT LINER

Applicant American Mfg., Inc.

K number K884751

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EBI 1988-10-20

BASE, DENTURE, RELINING, REPAIRING, REBASING,RESIN

Applicant Austenal Dental, Inc.

K number K883799

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EBI 1988-08-12

TRIAD ORTHODONTIC GEL

Applicant Dentsply Intl.

K number K882482

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EBI 1988-07-21

DENT-URE LINER SOFT RESILIENT DENTURE LINING MATER

Applicant Cadco Dental Products, Inc.

K number K881245

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EBI 1987-12-23

2ND MODIFIED VINYLAC PRESS PACK DENTURE RESIN

Applicant Astron Dental Corp.

K number K874025

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EBI 1987-11-20

ACRYLIC BASE DENTURE MATERIALS

Applicant E&D Dental Manufacturing Co.

K number K873738

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EBI 1987-08-10

LIGHT CURE DENTURE GLAZE

Applicant Austenal Dental, Inc.

K number K871849

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EBI 1987-06-17

LINER OR GSRI-PNF

Applicant Gulf South Research Institute

K number K871497

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EBI 1987-05-19

LUTEMOLL (BIOPLAST)

Applicant B. L. Dental Co.

K number K871038

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EBI 1987-04-15

FIBREFLEX

Applicant Biomedical Composites, Ltd.

K number K871312

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EBI 1987-03-19

STEADY RESIN

Applicant Great Lakes Orthodontics, Ltd.

K number K870908

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EBI 1987-03-11

AUSTENAL ACUPAC 20 DENTURE BASE MATERIAL

Applicant Austenal Dental, Inc.

K number K863630

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EBI 1987-02-25

SR 3/60 NF DENTURE MATER. & SELF-CURE DENT. RESIN

Applicant Ivoclar USA, Inc.

K number K864708

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EBI 1987-02-19

DURA ORTHO ACRYLIC

Applicant Reliance Dental Mfg. Co.

K number K870148

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EBI 1987-02-19

AUSTENAL ACUSOFT SOFT LINER

Applicant Austenal Dental, Inc.

K number K862557

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EBI 1987-02-10

MODIFIED VINYLAC PRESS PACK DENTURE RESIN

Applicant Astron Dental Corp.

K number K864757

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EBI 1987-02-10

IVOCRYL HEAT CURE & IVOCRYL QUICK DENTURE MATERIAL

Applicant Ivoclar USA, Inc.

K number K864709

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EBI 1986-09-05

TRIAD IMPACT

Applicant Dentsply Intl.

K number K863324

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EBI 1986-07-18

AUSTENAL ACUPAC HI DENTURE BASE MATERIAL

Applicant Austenal Dental, Inc.

K number K862558

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EBI 1986-04-17

ACRYLIC SOLDER

Applicant Parker Laboratories, Inc.

K number K861239

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EBI 1986-04-04

EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA

Applicant Psp Dental Co., Ltd.

K number K853094

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EBI 1985-09-23

DURA CONDITIONER

Applicant Reliance Dental Mfg. Co.

K number K852741

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EBI 1985-05-22

DENTAL ACRYLIC POLYMERS

Applicant Cole Polymers , Ltd.

K number K850650

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EBI 1984-12-03

CREDENT RADIOPAQUE DENTURE RESIN

Applicant Credent Co.

K number K842477

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EBI 1984-12-03

CREDENT RADIOPAQUE CROWN & BRIDE

Applicant Credent Co.

K number K842476

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EBI 1984-09-27

CLEAR LINER

Applicant Harry J. Bosworth Co.

K number K842576

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EBI 1984-07-19

ASTRON 77 INJECTION DENTURE RESIN

Applicant Astron Dental Corp.

K number K833270

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EBI 1984-05-01

BOSWORTH DENT-ALL

Applicant Harry J. Bosworth Co.

K number K840405

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EBI 1984-04-17

RESIL

Applicant Parker Laboratories, Inc.

K number K840548

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