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 2026-08-27

Glidewell™ Denture Base Resin

Applicant Prismatik Dentalcraft, Inc.

K number K261802

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EBI 2026-08-13

UltraPrint Flexible Denture UV

Applicant Guangzhou Heygears IMC., Inc.

K number K261626

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EBI 2026-07-31

NanoCeram Resin

Applicant 3BFAB TEKNOLOJI A.S.

K number K262681

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EBI 2026-07-08

Denture Base Resin V2

Applicant Formlabs Ohio, Inc.

K number K262300

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EBI 2026-07-01

DENTCA Tru Flexible

Applicant Dentca, Inc.

K number K261474

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EBI 2026-06-02

DB 4000 High Impact Denture Base

Applicant Carbon, Inc.

K number K260569

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EBI 2026-05-06

Denture Base

Applicant Shandong Huge Dental Material Corporation

K number K260376

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EBI 2025-11-25

LuxCreo Flexible Partial Denture Resin

Applicant LuxCreo, Inc.

K number K253365

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EBI 2025-11-21

TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000)

Applicant Graphy, Inc.

K number K253681

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EBI 2025-11-20

UltraPrint-Dental Denture UV

Applicant Guangzhou Heygears IMC., Inc.

K number K253324

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EBI 2025-10-30

Freeprint® denture flex

Applicant Detax GmbH

K number K252430

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EBI 2025-09-17

DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White)

Applicant Kamemizu Chemical Industry Co., Ltd.

K number K252035

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EBI 2025-06-25

Flexible Partial Resin

Applicant Prismatik Dentalcraft, Inc.

K number K250302

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EBI 2025-06-03

Partial Flex

Applicant Clemde SA DE CV

K number K242897

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EBI 2025-05-20

FP3D

Applicant Keystone Industries

K number K250489

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EBI 2025-04-29

Apex Flex

Applicant Sprintray, Inc.

K number K250617

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EBI 2025-04-11

Asiga DentaBASE

Applicant Asiga Pty, Ltd.

K number K243356

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EBI 2025-03-31

Denture Base Resin DT20

Applicant Hangzhou SHINING3D Dental Technology Co., Ltd.

K number K250946

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EBI 2024-12-23

Denture Base

Applicant Riton 3D Technology Co., Ltd.

K number K243103

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EBI 2024-12-17

Lucitone Digital Print Denture™ System

Applicant Dentsply Sirona, Inc.

K number K243336

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EBI 2024-11-22

Additively Manufactured Denture Resin

Applicant Aidite (Qinhuangdao) Technology Co., Ltd.

K number K242884

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EBI 2024-10-24

KeyPrint KeyDenture Base

Applicant Keystone Industries

K number K241089

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EBI 2024-09-12

Glidewell™ 3DP Denture Base Resin

Applicant Prismatik Dentalcraft, Inc.

K number K241493

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EBI 2024-09-04

NextDent Jet Denture Base; NextDent Jet Denture Teeth

Applicant Vertex-Dental B.V.

K number K241071

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EBI 2024-06-20

RODIN Titan 3D Resin

Applicant Belport Company, Inc., Gingi-Pak

K number K240688

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EBI 2024-03-05

BASIS FLOW II

Applicant YAMAHACHI DENTAL MFG., Co.

K number K233859

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EBI 2024-02-23

Ivotion Base Print

Applicant Ivoclar Vivadent, Inc.

K number K233995

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EBI 2023-11-27

PF Keep; Cad Cam Keep Block

Applicant Clemde SA DE CV

K number K233171

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EBI 2023-10-20

Lucitone Digital Print Denture System

Applicant Dentsply Sirona

K number K231578

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EBI 2023-10-20

NextDent Base

Applicant Vertex-Dental B.V.

K number K231388

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EBI 2023-09-05

Polibond

Applicant Zirkonzahn Srl

K number K232691

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EBI 2023-08-16

Harvest Dental HD Gum Strip

Applicant Harvest Dental Products, LLC

K number K231389

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EBI 2023-07-14

OnX Tough

Applicant Sprintray, Inc.

K number K230445

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EBI 2023-06-23

DD medical polymers (PMMA)

Applicant Dental Direkt GmbH

K number K230410

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EBI 2023-05-12

Harvest Printable Resin

Applicant Harvest Dental Products, LLC

K number K222489

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EBI 2023-04-13

Trusana™

Applicant Myerson, LLC

K number K230098

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EBI 2023-04-06

ACRIFIX

Applicant Deltamed GmbH

K number K230341

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EBI 2023-03-17

Denture Base Resin

Applicant Aidite (Qinhuangdao) Technology Co., Ltd.

K number K230115

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EBI 2022-11-17

Dentca Base Premium, Dentca Base Hi-Impact

Applicant Dentca, Inc.

K number K220042

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EBI 2022-11-10

SprintRay High Impact Denture Base

Applicant Sprintray, Inc.

K number K221678

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EBI 2022-09-21

V-Print dentbase

Applicant Voco GmbH

K number K220236

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EBI 2022-09-14

SprintRay Denture Base

Applicant Sprintray, Inc.

K number K220979

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EBI 2022-08-12

Denture Base Polymers

Applicant Shandong Huge Dental Material Corporation

K number K220680

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EBI 2022-08-11

TERA HARZ DENTURE

Applicant Graphy, Inc.

K number K222414

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EBI 2022-07-07

Stratasys TrueDent

Applicant Stratasys, Ltd.

K number K220771

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EBI 2022-07-05

CediTEC

Applicant Voco GmbH

K number K220743

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EBI 2022-06-22

Glidewell 3DP Denture Base Resin

Applicant Prismatik Dentalcraft, Inc.

K number K213765

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EBI 2022-03-04

Flexible Block

Applicant Shandong Huge Dental Material Corporation

K number K213994

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EBI 2022-01-10

3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix

Applicant Deltamed GmbH

K number K212541

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EBI 2021-07-28

Pac-Dent Denture Base Resin

Applicant Pac-Dent, Inc.

K number K210189

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EBI 2021-05-05

GR-14 Resin System

Applicant Pro3Dure Medical GmbH

K number K210298

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EBI 2021-03-30

E-Denture Pro

Applicant Envisiontec GmbH

K number K203641

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EBI 2021-03-23

DIOnavi-Denture02

Applicant Dio Corporation

K number K210828

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EBI 2020-11-19

FotoDent denture

Applicant Dreve Dentamid GmbH

K number K200580

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EBI 2020-11-16

Freeprint denture

Applicant Detax GmbH & Co. KG

K number K200461

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EBI 2020-10-22

DIOnavi-Denture

Applicant Dio Corporation

K number K193623

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EBI 2020-08-18

BB Base 3D printing resin for denture base

Applicant Enlighten Materials Co., Ltd.

K number K191591

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EBI 2020-07-31

Flex Fit

Applicant Dk Mungyo Corporation

K number K190790

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EBI 2020-01-29

VITA VIONIC Bond

Applicant Vita Zanhnfabrik H. Rauter GmbH Co.

K number K191926

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EBI 2019-11-01

NextDent Denture 3D+

Applicant Vertex-Dental B.V.

K number K191497

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EBI 2019-10-04

Tokuyama Rebase III

Applicant Tokuyama Dental Corporation

K number K190940

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EBI 2019-08-26

Halley resin system

Applicant Dentsply Sirona

K number K191427

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EBI 2019-04-24

Halley resin

Applicant Dentsply Sirona

K number K190043

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EBI 2018-12-21

JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White

Applicant Juvora, Ltd.

K number K181331

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EBI 2018-12-18

Lucitone Denture Base Materials

Applicant Dentsply Sirona

K number K182422

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EBI 2018-10-12

Juell 3D Volo Base

Applicant Park Dental Research Corporation

K number K181220

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EBI 2018-04-27

Keymill

Applicant Mycone Dental Supply Company, Inc. (Aka Keystone Industries)

K number K172764

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EBI 2018-01-16

Yamahachi Pink CAD/CAM Disk

Applicant YAMAHACHI DENTAL MFG., Co.

K number K172683

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EBI 2017-11-02

Duracetal

Applicant The Myerson Company Limited

K number K172407

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EBI 2017-10-02

Nobilplast Denture Resin

Applicant Cmp Industries, LLC

K number K170375

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EBI 2017-07-05

TOKUYAMA CUREGRACE

Applicant Tokuyama Dental Corporation

K number K170549

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EBI 2017-06-30

NextDent Denture, E-Denture

Applicant Vertex-Dental B.V.

K number K162572

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EBI 2017-05-31

Orthodontic Acrylic 2

Applicant Lang Dental Manufacturing Co., Inc.

K number K163482

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EBI 2017-03-13

mollosil plus

Applicant Detax GmbH & Co. KG

K number K162654

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EBI 2017-03-03

Dentca Denture Base II

Applicant Dentca, Inc.

K number K162044

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EBI 2017-02-13

JUVORA Dental Disc, Ceramill PEEK by JUVORA

Applicant Juvora

K number K160918

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EBI 2016-10-06

Pour Acrylic

Applicant Dentsply Sirona

K number K161330

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EBI 2016-09-28

PINK CAD/CAM disc

Applicant Polident D.O.O., Dental Products Industry

K number K153546

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EBI 2016-09-02

JET SET 4 DENTURE REPAIR RESIN

Applicant Lang Dental Manufacturing Company, Inc.

K number K152981

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EBI 2016-06-15

Dentivera Milling Disc

Applicant Dental Solutions, LLC

K number K160498

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EBI 2016-04-22

AvaDent Denture Base Material

Applicant Global Dental Science

K number K153590

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EBI 2016-03-22

ClearMet

Applicant Mycone Dental Supply Co., T/A Keystone Industries

K number K152051

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EBI 2016-03-03

GC Reline II

Applicant GC America, Inc.

K number K153253

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EBI 2013-08-22

PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS

Applicant Merz Dental GmbH

K number K130076

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EBI 2013-07-26

ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS

Applicant Dentsoll, Inc.

K number K130680

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EBI 2013-07-12

YAMAHACHI DENTURE BASE RESINS

Applicant Yamahachi Dental Manufacturing Co.

K number K131036

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EBI 2013-03-01

VERTEX THERMOSENS RIGID

Applicant Vertex-Dental B.V.

K number K123220

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EBI 2013-01-10

I.FLEX BY TCS

Applicant Thermoplastic Comfort Systems, Inc.

K number K123396

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EBI 2012-10-15

QUARTZ SPLINT SYSTEM (UD, WOVEN, ROPE, MESH) QUARTZ SPINT RESIN QS FLOW

Applicant Recherches Techniques Dentaires (R.T.D.)

K number K122348

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EBI 2012-04-10

DEFLEX

Applicant Nuxen S.R.L.

K number K113608

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EBI 2012-03-16

DEFLEX ACRILATO

Applicant Nuxen S.R.L.

K number K113788

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EBI 2011-11-18

FOUNDATION DENTAL RESIN

Applicant Unix-Japan Co., Ltd.

K number K111709

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EBI 2011-11-04

ORTHO-JET CRYSTAL

Applicant Lang Dental Mfg. Co., Inc.

K number K112397

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EBI 2011-10-28

SOFRELINER TOUGH S

Applicant Tokuyama Dental Corporation

K number K112445

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EBI 2011-09-29

PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID

Applicant Heraeus Kulzer, LLC

K number K111832

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EBI 2011-09-12

JUELL SOFT CURE

Applicant Juell Dental

K number K111178

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EBI 2011-09-12

JUELL HARD CURE

Applicant Juell Dental

K number K111177

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EBI 2011-05-04

QUICK UP

Applicant Voco GmbH

K number K110440

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EBI 2011-04-29

PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID

Applicant Heraeus Kulzer, LLC

K number K110037

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EBI 2011-03-28

NEW STETIC ACRYLICS

Applicant New Stetic

K number K102874

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