Crown And Bridge, Temporary, Resin

FDA product code EBG · 180 cleared devices

Class 2 Dental

Regulation: 21 CFR 872.3770
Review panel: DE
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-07-15 – 2026-04-17

EBG 2026-04-17

Dura-Arch

Applicant Hangzhou SHINING3D Dental Technology Co., Ltd.

K number K261261

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EBG 2026-03-02

“FLNT Base” and “FLNT Temp”

Applicant Liaoning Upcera Co., Ltd.

K number K253380

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EBG 2025-06-23

TempFIT Temporary Crown and Bridge Resin

Applicant Rizhao Huge Biomaterials Company, Ltd.

K number K251271

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EBG 2025-05-05

DentaTOOTH

Applicant Asiga Pty, Ltd.

K number K243370

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EBG 2025-04-22

Evoblock, Perléon

Applicant Evoden Indústria Comércio Importação E Exportação

K number K243621

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EBG 2025-02-21

TEMP MASTER, PMMA-based dental resin

Applicant Taiwan Dental Materials Co., Ltd.

K number K243951

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EBG 2024-11-26

Digital Temp

Applicant Sprintray, Inc.

K number K242559

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EBG 2024-11-26

PrimmaArt

Applicant Dentscare Ltda

K number K231859

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EBG 2024-07-19

Premium Teeth Resin

Applicant Formlabs Ohio, Inc.

K number K240538

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EBG 2024-05-31

Fixtemp® C&B 4:1

Applicant Dreve Denatmid GmbH

K number K241226

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EBG 2024-05-23

dima Print Teeth & Temp

Applicant Kulzer, LLC

K number K233868

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EBG 2023-05-12

PMMA BLOCK

Applicant Huliang(Shanghai) Bio-Tech Co., Ltd.

K number K223706

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EBG 2023-02-16

PMMA Blocks for Dental Use

Applicant Aidite (Qinhuangdao) Technology Co., Ltd.

K number K223477

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EBG 2022-12-21

CURA-Temp

Applicant Mgnewton , Ltd.

K number K202965

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EBG 2022-03-10

Hexa-Temp

Applicant Spident Co., Ltd.

K number K214071

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EBG 2022-01-14

UltraPrint-Dental Temp C&B UV

Applicant Guangzhou Heygears IMC., Inc.

K number K213643

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EBG 2021-12-08

C&B 5.0 Hybrid

Applicant Arum Dentistry Co., Ltd.

K number K210817

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EBG 2021-06-14

E-Temp

Applicant Envisiontec GmbH

K number K211101

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EBG 2021-04-09

PuRE PMMA Disc

Applicant Quest Dental USA Corp.

K number K201563

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EBG 2020-12-17

Aidite PMMA

Applicant Aidite (Qinhuangdao) Technology Co., Ltd.

K number K190217

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EBG 2020-11-05

GR-17 Resin System

Applicant Pro3Dure Medical GmbH

K number K201827

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EBG 2020-11-03

PMMA Block

Applicant Huge Dental Material Co., Ltd.

K number K201683

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EBG 2020-10-27

FREEPRINT temp

Applicant Detax GmbH & Co. KG

K number K200273

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EBG 2020-09-09

Structur CAD

Applicant Voco GmbH

K number K201090

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EBG 2020-09-02

Bright Temporary C&B

Applicant Dmp Dental Industry S.A.

K number K192830

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EBG 2020-07-31

P pro Crown & Bridge

Applicant Deltamed GmbH

K number K200039

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EBG 2020-07-09

GC Temp Print

Applicant GC America, Inc.

K number K193113

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EBG 2020-07-08

ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA

Applicant Zirkonzahn Srl

K number K200676

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EBG 2020-05-18

VarseoSmile Temp

Applicant Bego Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG

K number K193553

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EBG 2020-05-05

AA temp temporary restoration 3D printing photoreactive resin

Applicant Enlighten Materials Co., Ltd.

K number K191590

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EBG 2020-02-13

DiaTemp

Applicant DiaDent Group International

K number K192158

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EBG 2020-02-13

DiaTemp Flow

Applicant DiaDent Group International

K number K192022

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EBG 2020-02-05

DENTCA Crown and Bridge

Applicant Dentca, Inc.

K number K192806

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EBG 2019-11-07

Portux CAD/CAM Disc

Applicant New Stetic, SA

K number K192153

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EBG 2019-10-04

Ceramill A-Temp

Applicant Amann Girrbach AG

K number K191843

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EBG 2019-09-11

TurboTemp EZ

Applicant Zest Anchors, LLC

K number K191619

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EBG 2019-09-05

SmarTemp X1

Applicant Parkell, Inc.

K number K190930

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EBG 2019-07-03

MD-Temp Plus

Applicant Meta Biomed Co., Ltd.

K number K190724

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EBG 2019-05-29

LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2

Applicant DMG Chemisch-Pharmazeutische Fabrik GmbH

K number K183337

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EBG 2018-12-13

EVOLUX CAD/CAM PMMA BLOCKS

Applicant Blue Dent Dental

K number K182065

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EBG 2018-12-12

Harvest Dental Polymer Blocks

Applicant Harvest Dental Products, LLC

K number K180578

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EBG 2018-12-07

Resin for Temporary Crown & Bridge

Applicant Dentis Co., Ltd.

K number K180657

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EBG 2018-06-28

TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT

Applicant Zirkonzahn GmbH

K number K180562

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EBG 2017-12-13

Fixtemp C&B

Applicant Dreve Dentamid GmbH

K number K171729

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EBG 2017-10-19

PuRE PMMA Disc

Applicant Quest Dental USA Corp.

K number K172281

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EBG 2016-05-13

DD medical polymers

Applicant Dental Direkt GmbH

K number K153490

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EBG 2016-05-11

Vericore Gradient Temporary Disc

Applicant Whip Mix Corporation

K number K152443

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EBG 2016-04-12

TelioCAD Multi

Applicant Ivoclar Vivadent, Inc.

K number K153753

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EBG 2016-01-19

DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR

Applicant Dentalplus GmbH

K number K152215

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EBG 2013-12-18

COPRA TEMP PMMA-DISK

Applicant White Peaks Dental Systems GmbH & Co. KG

K number K131664

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EBG 2013-02-21

PEKKTON IVORY

Applicant Cendres & Metaux SA

K number K123638

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EBG 2012-12-27

KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B

Applicant Kettenbach GmbH & Co. KG

K number K122039

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EBG 2012-10-09

BRIGHTGLASS BRIGHTGLASS M

Applicant Ktk Medical Supplies GmbH

K number K122025

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EBG 2012-08-28

PMMA CAD/CAM DISC

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

K number K112967

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EBG 2012-06-08

TUFF-TEMP 2.0

Applicant Pulpdent Corporation

K number K120784

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EBG 2012-06-01

STRUCTUR 3

Applicant Voco GmbH

K number K120779

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EBG 2011-11-08

FIBER DISK AND BLOCK

Applicant Bioloren S.R.L.

K number K112186

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EBG 2011-09-07

EVADYNE TEMPORARY CROWN AND BRIDGE RESIN

Applicant Neodental Chemical Products Co., Ltd.

K number K111666

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EBG 2011-06-17

FIXTEMP C&B

Applicant Exacta Dental Direct, Inc.

K number K102917

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EBG 2011-06-14

TEMPFLEX

Applicant Kerr Corporation

K number K110747

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EBG 2011-05-25

PRO-V COAT

Applicant Bisco, Inc.

K number K103514

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EBG 2011-05-17

SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL

Applicant Novocol, Inc.

K number K110484

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EBG 2011-02-18

EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM

Applicant Deltamed GmbH

K number K102776

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EBG 2011-02-14

TELIO CS INLAY & TELIO CS ONLAY

Applicant Ivoclar Vivadent, Inc.

K number K103379

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EBG 2011-02-07

ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT)

Applicant Micerium S.P.A.

K number K103474

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EBG 2011-02-04

TURBO TEMP 3

Applicant Danville Materials, Inc.

K number K102753

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EBG 2010-12-16

VIPI BLOCK

Applicant Vipi Industria,Comercio,Exportacao E Importacao DE

K number K102341

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EBG 2010-09-28

LUXATEMP ULTRA /STAR

Applicant Dmg USA, Inc.

K number K101710

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EBG 2010-09-27

DIRECT CROWN NATURAL 1

Applicant Candulor USA, Inc.

K number K101814

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EBG 2010-03-10

TELIO CAD

Applicant Ivoclar Vivadent, Inc.

K number K093708

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EBG 2010-03-05

MIZZY EXPRESS

Applicant Mycone Dental Supply Co., Inc.

K number K093380

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EBG 2009-07-23

TEMPORARY C&B COMPOSITE

Applicant Voco GmbH

K number K091894

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EBG 2009-06-05

MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN

Applicant Lang Dental Mfg. Co., Inc.

K number K083195

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EBG 2008-12-09

TEMPORARY COLD.V AND SELF-CURE DENTINE

Applicant Major Prodotti Dentari S.P.A.

K number K082700

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EBG 2008-09-17

PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL

Applicant Pulpdent Corporation

K number K081810

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EBG 2008-09-17

LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESIN

Applicant Lang Dental Mfg. Co., Inc.

K number K081705

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EBG 2008-05-02

ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLEACH SHADES

Applicant Merz Dental GmbH

K number K080556

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EBG 2008-04-18

MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM

Applicant Dentsply Interntional

K number K080311

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EBG 2008-04-11

UNIFAST III

Applicant GC America, Inc.

K number K073106

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EBG 2008-04-08

ZENO PMMA DISC

Applicant Wieland Dental + Technik GmbH & Co. KG

K number K080182

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EBG 2008-02-14

PRO-V

Applicant Bisco, Inc.

K number K073263

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EBG 2008-01-09

TEMPXN28

Applicant 3M Espe AG Dental Products

K number K073296

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EBG 2007-08-21

WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLORED

Applicant Merz Dental GmbH

K number K071548

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EBG 2007-06-01

VITA CAD-TEMP FOR INLAB, MODEL, VX59-4002, VX59-4010, VX59-4102, VX59-4110, VX59-4202, VX59-4210, VX59-4302, VX59-4310

Applicant Vita

K number K070991

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EBG 2007-02-08

KAVO EVEREST C-TEMP

Applicant Kavo America

K number K063624

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EBG 2006-09-13

ARTEGRAL IMCROWN

Applicant Merz Dental GmbH

K number K061809

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EBG 2006-07-21

MD-TEMP

Applicant Meta Biomed Co., Ltd.

K number K061530

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EBG 2006-05-23

TEMPFX ESTHETIC PROVISIONAL SYSTEM

Applicant Dentsply International, Inc.

K number K061264

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EBG 2006-05-16

TEMPORARY CROWN & BRIDGE RESIN

Applicant Cosmedent, Inc.

K number K060881

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EBG 2006-03-07

PROVISIONAL INLAY/ONLAY KIT

Applicant Dmg USA, Inc.

K number K052800

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EBG 2006-02-17

TEMPORARY CROWN AND BRIDGE MATERIAL

Applicant Dentsply International, Inc.

K number K060293

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EBG 2005-12-09

BREFORMANCE

Applicant Bredent-Products For the Dental Technician Laborat

K number K052781

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EBG 2004-12-14

SYSTEMP.C&B PLUS

Applicant Ivoclar Vivadent, Inc.

K number K042820

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EBG 2004-08-04

PROVISO

Applicant Scientific Pharmaceuticals, Inc.

K number K041886

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EBG 2004-05-19

SR ADORO

Applicant Ivoclar Vivadent, Inc.

K number K040951

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EBG 2004-05-13

COOL TEMP NATURAL

Applicant Coltene AG

K number K041098

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EBG 2004-04-07

STRUCTUR 2 SC

Applicant Voco GmbH

K number K040769

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EBG 2004-01-16

LUXAFORM PLUS

Applicant Dmg USA, Inc.

K number K033227

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EBG 2004-01-15

LEXATITE QUICK ACRYLIC

Applicant Imtec Corp.

K number K033432

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EBG 2003-11-21

PROTEMP 3 GARANT

Applicant 3M Espe AG Dental Products

K number K033022

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