Prosthetic devices · 21 CFR 872 Subpart D
Resin Temporary Crown and Bridge
FDA device type “Crown And Bridge, Temporary, Resin”.
- Companies listing it
- 14488 makers
- Brands and models
- 366
- 510(k) clearances
- 18917 in five years
- FDA name
- Crown And Bridge, Temporary, Resin
510(k) clearances per year, 1976–2026
Companies that list EBG
144 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Institut Straumann AG | Switzerland | Maker | polycon ae restoration | 212 | 2026 |
| Dentsply Sirona, Inc. | United States | Maker | Essix (Sports) Mouthguard · Essix A+ · Essix ACE · Essix C+ · +10 | 148 | 2026 |
| Prismatik Dentalcraft, Inc. | United States | Maker | BioTemps NOW Milling Block;Bridge Block;A1 (5-pack) · BioTemps NOW Milling Block;Bridge Block;A2 (5-pack) · BioTemps NOW Milling Block;Bridge Block;A3 (5-pack) · BioTemps NOW Milling Block;Bridge Block;A3.5 (5-pack) · +11 | 56 | 2026 |
| Dentis Co., Ltd. | South Korea | Maker | ZMD-1000B TEMPORARY | 37 | 2026 |
| ARUM DENTISTRY Co., Ltd | South Korea | Maker | C&B 5 Hybrid · C&B NFH Hybrid | 17 | 2025 |
| Spident Co., Ltd. | South Korea | Maker | EsTemp C&B · Temporary Crown & Bridge Material | 22 | 2026 |
| Aidite (Qinhuangdao) Technology Co., Ltd | China | Maker | Additive Manufacturing (Light Curing) Crown Bridge Resin · FREEPRINT crown · PMMA Blocks for Dental Use · 3D Printing Material Crown Bridge · +1 | 16 | 2026 |
| Voco GmbH | Germany | Maker | Structur 2 QM · Structur 2 SC · Structur 3 · Structur CAD · +3 | 117 | 2026 |
| Rizhao HuGe Biomaterials Company, Ltd. | China | Maker | TempFIT Temporary Crown and Bridge Resin | 13 | 2025 |
| DiaDent Group International | South Korea | Maker | DiaTemp · DiaTemp Flow | 24 | 2026 |
| Shofu Inc | Japan | Maker | DENTADISC · SHOFU BLOCK HC · SHOFU BLOCK HC HARD · SHOFU DISK HC | 96 | 2025 |
| SprintRay Inc. | United States | Maker | Crown HT (A1, A2, A3, B1, Unpigmented, Bleach) · Digital Temp (A1, A2, B1, Bleach) | 8 | 2026 |
| GC America Inc. | United States | Maker | Alike · Cerasmart · Cerasmart 270 · Cerasmart Universal · +9 | 137 | 2026 |
| Zest Anchors, LLC | United States | Maker | — | 26 | 2026 |
| Sybron Dental Specialties | United States | Maker | Construct · Fill-In · Modeling Resin · Temphase · +2 | 203 | 2026 |
| Kulzer, LLC | United States | Maker | dima Print Teeth & Temp | 37 | 2026 |
| Prevest Denpro Limited | India | Maker | Prevest C&B Ceramic Resin · Prevest C&B Interim Resin · Prevest C&B Permanent Resin | 7 | 2024 |
| Hangzhou SHINING3D Dental Technology Co., Ltd | China | Maker | Dura-Arch · Dura-Crown · Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) | 6 | 2026 |
| Ivoclar Vivadent, AG | United States | Maker | SR Ivocron · SR Link · Telio CAD · Telio CAD disc · +7 | 94 | 2026 |
| Graphy, Inc. | South Korea | Maker | TERA HARZ · Tera Harz II | 6 | 2025 |
| Meta Biomed Co, Ltd | United States | Maker | MD-Temp · MD-Temp Plus | 24 | 2024 |
| Liaoning Upcera Co., Ltd | China | Maker | PMMA Blocks, FLNT Temp, FLNT Base | 10 | 2026 |
| Shandong Huge Dental Material Corporation | China | Maker | BioTemps NOW Milling Blocks · NOBILCAM PMMA Disc · PMMA BLOCK | 8 | 2026 |
| Deltamed GmbH | Germany | Maker | P pro Crown & Bridge · PRO Resins Arch X · RS VIVO C&B Ultimate · 3Delta Etemp · +1 | 6 | 2024 |
| Saremco Dental AG | Switzerland | Maker | saremco print Crowntec | 4 | 2025 |
| Kettenbach GmbH & Co. KG | Germany | Maker | Visalys Temp | 14 | 2026 |
| Imagine Milling Technologies, LLC | United States | Maker | Harvest Dental Polymer Blocks | 4 | 2026 |
| Guangzhou Heygears IMC., Inc. | China | Maker | UltraPrint Temp C&B UV | 3 | 2026 |
| Whitepeaks Dental Solutions GmbH | Germany | Maker | CopraTemp | 3 | 2024 |
| Parkell, Inc | United States | Maker | Smartemp | 58 | 2025 |
| Dentscare Ltda | Brazil | Maker | 3007210751 | 10 | 2024 |
| Zirkonzahn Srl | Italy | Maker | — | 10 | 2023 |
| Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | Germany | Maker | CAD Temp · VITA Vionic Dent Disc Resin | 8 | 2026 |
| Vertex-Dental B.V. | Netherlands | Maker | NextDent Jet Base · NextDent Jet Teeth · Saremco Print Crowntec | 7 | 2024 |
| Dentca, Inc. | United States | Maker | DENTCA Crown and Bridge | 6 | 2026 |
| DMP Dental Industry S.A. | Greece | Maker | BRIGHT TEMPORARY C&B | 3 | 2026 |
| Yamahachi Dental Mfg. Co. | Japan | Maker | Yamahachi PMMA Disks | 3 | 2026 |
| Keystone Industries | United States | Maker | Trim · Trim II | 2 | 2025 |
| Detax GmbH | Germany | Maker | FREEPRINT® crown A3,5 1000g · FREEPRINT® crown A3,5 500g · tempofit premium B1 · tempofit premium BL · +18 | 2 | 2025 |
| Formlabs Inc. | United States | Maker | Premium Teeth Resin | 2 | 2026 |
| Asiga | Australia | Maker | DentaTOOTH | 2 | 2025 |
| Clemde SA DE CV | Mexico | Maker | PF Keep / Cad Cam Peek Block | 2 | 2025 |
| Graphenano Dental, SL | Spain | Maker | G-CAM | 2 | 2025 |
| MGNEWTON Ltd. | South Korea | Maker | CURA-Temp | 2 | 2023 |
| Coltene/Whaledent AG | Switzerland | Maker | Cool Temp Natural | 45 | 2022 |
| J. Morita USA, Inc. | United States | Maker | CB Temp Temporary Crown & Bridge Material | 42 | 2022 |
| Dreve Dentamid GmbH | Germany | Maker | Fixtemp C&B 4:1 | 6 | 2025 |
| New Stetic, SA | Colombia | Maker | Duracryl · EZ-Cryl · Fidelity · Novacryl · +6 | 5 | 2026 |
| DMG Chemisch-Pharmazeutische Fabrik GmbH | Germany | Maker | Kit LX-Plus A2+Ionosit BL · Kit LX-Ultra A2+Ionosit BL · Luxatemp AM Plus 1+15 A1 USA · Luxatemp AM Plus 1+15 A2 Intro · +30 | 4 | 2022 |
| Amann Girrbach AG | Austria | Maker | Ceramill A-Temp · Ceramill A-Temp ML | 3 | 2026 |
| Dental Manufacturing S.p.A. | Italy | Maker | ACRY PRINT 3D RU-001 TEMPORARY · RUTHINIUM DISC · RUTHINIUM DISC MULTILAYER · RUTHINIUM DISC MULTILAYER SC | 1 | 2026 |
| Stratasys Ltd | Israel | Maker | TrueDent Clear · TrueDent Cyan · TrueDent Magenta · TrueDent White · +1 | 1 | 2022 |
| Shenzhen Piocreat 3D Technology Co., Ltd | China | Maker | Denture Base Resin(PN-Denture (Red,White)) | 1 | 2024 |
| Huliang (shanghai) Bio-Tech Co., Ltd. | China | Maker | Perfect PMMA · PMMA BLOCK | 1 | 2023 |
| Pulpdent Corporation | United States | Maker | Tuff-Temp Plus Provisional Veneer, Crown & Bridge Resin · Tuff-Temp Provisional Add-On · Tuff-Temp Provisional C & B Resin · Tuff-Temp Provisional Glaze | 107 | 2021 |
| Scientific Pharmaceuticals | United States | Maker | Sci-Span | 73 | 2020 |
| Reliance Orthodontic Products, Inc. | United States | Maker | — | 32 | 2021 |
| Sterngold | United States | Maker | EZ Pickup Material · Instatemp Max | 24 | 2017 |
| S & C Polymer GmbH | Germany | Maker | — | 20 | 2009 |
| Bicon, LLC | United States | Maker | TRINIA | 18 | 2015 |
| Lang Dental Mfg. Co., Inc. | United States | Maker | Jet Set-4 · JET TOOTH SHADE · Mach 4 Jet Tooth Shade Acrylic · PulseTemp · +2 | 9 | 2011 |
| Merz Dental GmbH | Germany | Maker | artBloc Temp · Ceramill Temp · Coritec PMMA Disc · M-PM Disc (Pink) · +3 | 8 | 2017 |
| Talladium, Inc. | United States | Maker | Luminesse Acetal · Luminesse PMMA · Luminesse Temporaries | 7 | 2016 |
| Schutz Dental GmbH | Germany | Maker | — | 7 | 2016 |
| Micerium S.P.A. | Italy | Maker | ENA TEMP · ENAMEL PLUS TEMP | 6 | 2011 |
| Psp Dental Co., Ltd. | United Kingdom | Maker | C&B Temp · Nucavfil | 6 | 1986 |
| Neodental Chemical Products Co., Ltd. | Japan | Maker | Evadyne | 5 | 2011 |
| Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO | Germany | Maker | Temporary CB · VarseoSmile Temp · VarseoSmile TriniQ | 4 | 2013 |
| Major Prodotti Dentari S.P.A. | Italy | Maker | self-cure.dentine · temporary.cold.v | 3 | 2008 |
| Bioloren S.R.L. | Italy | Maker | Fiber Disks and Blocks | 3 | 2018 |
| Advantage Dental Products, Inc. | United States | Maker | Matrix Buttons · MATRIXTEMP | 3 | 1999 |
| pro3dure medical GmbH | Germany | Maker | ACRY Print RU-001 temporary · FLOW C&B · GR-17 temporary · GR-17.1 temporary lt; Structomer Temps | 2 | 2021 |
| Dental Technologies, Inc. | United States | Maker | Alpha-Dent Temporary Crown & Bridge | 2 | 2013 |
| Manufacturera Dental Continental | Mexico | Maker | Bisacryl NicTone · Nic Tone Acrylic Resins · Nic Tone PolyCril · Nic Tone Selfcure Liquid | 2 | 2001 |
| Polident d.o.o. | Slovenia | Maker | DD poly Y ML · Pink CAD/CAM Disc · PMMA CAD/CAM disc | 2 | 2016 |
| anax dent GmbH | Germany | Maker | anaxGLAZE · New Outline · PMMA BLANKS · Visco III | 2 | 2012 |
| Enlighten Materials Co., Ltd. | Taiwan | Maker | AA temp temporary restoration 3D printing photoreactive resin | 2 | 2020 |
| Union Dental S.A. | Spain | Maker | ANAXDENT PMMA BLANK · CORiTEC PMMA DISC Monolayer & Multilayer · IDODENTINE BLOCK · IDODENTINE DISC · +2 | 1 | 2015 |
| Blue Dent Dental | Brazil | Maker | CROWN AND BRIDGE, TEMPORARY, RESIN | 1 | 2018 |
| Identa Dental Material GmbH | Germany | Maker | IDENTA SC Temp C&B Material · IDENTA SC Temp C&B Material 4:1 · IDENTA SC Temp C&B Material Plus · IDENTA SC Temp C&B Material QM | — | — |
| Solventum US LLC | United States | Maker | — | — | — |
| Evoden Industria Comercio Importacao e Exportacao de Produto | Brazil | Maker | Evoblock · Perleon | — | — |
| Leixir Resources Private Limited | India | Maker | Lucitone Digital Print Denture System | — | — |
| UFP Technologies, Inc. | United States | Maker | Tooth Shade Resin Material | — | — |
| Shenzhen Jiahong Dental Technology Co., Ltd | China | Maker | EBG | — | — |
| Bird-X, Inc. | United States | Maker | Coldpac Tooth Acrylic | — | — |
| MyoHealth Technologies, LLC | United States | Maker | Myoaligner Appliance | — | — |
| Midwest Tek | United States | Maker | Matrix Buttons | — | — |
| Ultradent Products, Inc. | United States | Contract manufacturer | ExperTemp | 95 | 2026 |
| Dental Direkt GmbH | Germany | Contract manufacturer | DD poly Y ML | 9 | 2024 |
| Young Innovations Inc | United States | Contract manufacturer | Temporary Crown and Bridge Maerial | 23 | 2025 |
| Harvest Dental Products, LLC | United States | Manufacturer | Poly Cast · PolyGum · PolySplint · Temp Esthetic · +2 | 5 | 2023 |
| Centrix, Inc. | United States | Contract manufacturer | — | 44 | 2025 |
| Cosmedent, Inc. | United States | Repacker / relabeler | CosmeTemp · MirrorImage · RSVP Heavy Body | 27 | 2024 |
| Den-Mat Holdings, LLC | United States | Manufacturer | Inspire Esthetic Provisional Composite · PERFECtemp II · Temptation® Now Fast Set Temporary Crown & Bridge Composite | 8 | 2026 |
| Pac-Dent Inc. | United States | Contract manufacturer | — | 5 | 2022 |
| Hunan Vsmile Biotechnology Co.,Ltd | China | Contract manufacturer | Acetal Flexible PMMA Block · PMMA Block · Removable resin | 2 | 2024 |
| The Argen Corporation | United States | Contract manufacturer | ArgenPMMA · ArgenPMMA EBG · ArgenPMMA EBI · ArgenPMMA MQC | 11 | 2024 |
| Jensen Industries, Inc. | United States | Manufacturer | — | 17 | 2019 |
| Dent Zar, Inc. | United States | Repacker / relabeler | — | 12 | 1996 |
| Synca Marketing | Canada | Foreign exporter | Biolight TEMP Crown and Bridge | 1 | 2010 |
| Sherpa | South Korea | Manufacturer | Deli-Temp | 1 | 2011 |
| DMG America, L.L.C. | United States | Contract manufacturer | Temp Tabs | 1 | 2013 |
| Exacta Dental Products, Inc. | United States | Repacker / relabeler | EXACTA Temp Xtra | 1 | 2006 |
| Sotera Health LLC | United States | Contract manufacturer | — | — | — |
| Jersey Dental Supplies | United States | Repacker / relabeler | CERASMART · GC PATTERN RESIN · INTEGRITY · LUXATEMP AUTOMIX · +4 | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | C&B · crown & Bridge · Luxatemp · Protemp · +5 | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson Temporary Crown and Bridge Material | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | C&B · Crown & Bridge · Dental Cement · denture · +7 | — | — |
| Samtrade Supplies Inc. | Canada | Foreign exporter | Cavit · Integrity C & B Material · Luxatemp C & B Material · Protemp · +1 | — | — |
| Premium Plus Dental | United States | Lister | — | — | — |
| Diadent Group Intl., Inc. | Canada | Foreign exporter | DiaTemp · DiaTemp Flow | — | — |
| CARGUS International Inc. | United States | Repacker / relabeler | — | — | — |
| LLD Care d.o.o. | Croatia | Foreign exporter | Integrity | — | — |
| Ortho Solutions LC | United States | Contract manufacturer | — | — | — |
| Meta Dental Corp. | United States | Repacker / relabeler | Md-Temp | — | — |
| anaxdent North America | United States | Lister | anaxdent · New Outline · Pekkton Ivory · 3Delta UNlimited | — | — |
| Dentonics Inc | United States | Repacker / relabeler | Master-Dent | — | — |
| Shenzhen Upcera Digital Dental Technology Co., Ltd | China | Foreign exporter | PMMA Blocks, FLNT Temp, FLNT Base | — | — |
| NU Radiance, Inc. | United States | Repacker / relabeler | Nu Form · Sentry Dental Temp. Crown & Bridge | — | — |
| Axiodent Inc. | United States | Repacker / relabeler | — | — | — |
| Sanicure BV | Netherlands | Foreign exporter | EBG - CROWN AND BRIDGE, TEMPORARY, RESIN EBF - Material, tooth shade, resin | — | — |
| Shenzhen Upcera Dental Technology Co., Ltd | China | Foreign exporter | PMMA Blocks, FLNT Temp, FLNT Base | — | — |
| Zapalign LLC | United States | Repacker / relabeler | — | — | — |
| Zapalign Inc. | South Korea | Foreign exporter | CROWN AND BRIDGE, TEMPORARY, RESIN | — | — |
| Dental Plus USA, LLC | United States | Repacker / relabeler | G-CAM · PMMA | — | — |
| DigiSmiles Lab | United States | Repacker / relabeler | temporary crown | — | — |
| Primotec LLC | United States | Repacker / relabeler | PREMIOtemp | — | — |
| Upcera Dental America Inc. | United States | Repacker / relabeler | — | — | — |
| Arvit Dental Laboratory Inc. | United States | Repacker / relabeler | Crown and Bridge, Temporary, Resin | — | — |
| HEXA Dental | United States | Contract manufacturer | — | — | — |
| indigodental GmbH | Germany | Foreign exporter | — | — | — |
| Opa Dental, LLC | United States | Repacker / relabeler | — | — | — |
| Premiere 1 Dental Laboratory, LLC | United States | Repacker / relabeler | Crown, Bridge, Temporary Resin, Porcelain Crown | — | — |
| Kash Sales Inc. | Canada | Foreign exporter | — | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| K Dent Global | United States | Repacker / relabeler | Crown & Bridge | — | — |
| Dylan Lucas International Inc | Canada | Foreign exporter | — | — | — |
| Frontier Dental Supply Inc | Canada | Foreign exporter | — | — | — |
| Klarity Medical Products | United States | Repacker / relabeler | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Tas Medical Supply | United States | Foreign exporter | — | — | — |
| Zircon Plus Limited | Israel | Foreign exporter | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 17 Apr 2026 | K261261 | Dura-Arch | Hangzhou SHINING3D Dental Technology Co., Ltd |
| 2 Mar 2026 | K253380 | FLNT Base and FLNT Temp | Liaoning Upcera Co., Ltd |
| 23 Jun 2025 | K251271 | TempFIT Temporary Crown and Bridge Resin | Rizhao HuGe Biomaterials Company, Ltd. |
| 5 May 2025 | K243370 | DentaTOOTH | Asiga |
| 22 Apr 2025 | K243621 | Evoblock, Perléon | Evoden Indústria Comércio Importação E Exportação |
| 21 Feb 2025 | K243951 | TEMP MASTER, PMMA-based dental resin | Taiwan Dental Materials Co., Ltd. |
| 26 Nov 2024 | K242559 | Digital Temp | SprintRay Inc. |
| 26 Nov 2024 | K231859 | PrimmaArt | Dentscare Ltda |
| 19 Jul 2024 | K240538 | Premium Teeth Resin | Formlabs Inc. |
| 31 May 2024 | K241226 | Fixtemp® C&B 4:1 | Dreve Denatmid GmbH |
| 23 May 2024 | K233868 | dima Print Teeth & Temp | Kulzer, LLC |
| 12 May 2023 | K223706 | PMMA BLOCK | Huliang (shanghai) Bio-Tech Co., Ltd. |
| 16 Feb 2023 | K223477 | PMMA Blocks for Dental Use | Aidite (Qinhuangdao) Technology Co., Ltd |
| 21 Dec 2022 | K202965 | CURA-Temp | MGNEWTON Ltd. |
| 10 Mar 2022 | K214071 | Hexa-Temp | Spident Co., Ltd. |
| 14 Jan 2022 | K213643 | UltraPrint-Dental Temp C&B UV | Guangzhou Heygears IMC., Inc. |
| 8 Dec 2021 | K210817 | C&B 5.0 Hybrid | ARUM DENTISTRY Co., Ltd |
| 14 Jun 2021 | K211101 | E-Temp | Envisiontec GmbH |
| 9 Apr 2021 | K201563 | PuRE PMMA Disc | Quest Dental USA Corp. |
| 17 Dec 2020 | K190217 | Aidite PMMA | Aidite (Qinhuangdao) Technology Co., Ltd |
| 5 Nov 2020 | K201827 | GR-17 Resin System | pro3dure medical GmbH |
| 3 Nov 2020 | K201683 | PMMA Block | Huge Dental Material Co., Ltd. |
| 27 Oct 2020 | K200273 | FREEPRINT temp | Detax GmbH & Co. KG |
| 9 Sep 2020 | K201090 | Structur CAD | Voco GmbH |
| 2 Sep 2020 | K192830 | Bright Temporary C&B | DMP Dental Industry S.A. |
| 31 Jul 2020 | K200039 | P pro Crown & Bridge | Deltamed GmbH |
| 9 Jul 2020 | K193113 | GC Temp Print | GC America Inc. |
| 8 Jul 2020 | K200676 | ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA | Zirkonzahn Srl |
| 18 May 2020 | K193553 | VarseoSmile Temp | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG |
| 5 May 2020 | K191590 | AA temp temporary restoration 3D printing photoreactive resin | Enlighten Materials Co., Ltd. |
| 13 Feb 2020 | K192158 | DiaTemp | DiaDent Group International |
| 13 Feb 2020 | K192022 | DiaTemp Flow | DiaDent Group International |
| 5 Feb 2020 | K192806 | DENTCA Crown and Bridge | Dentca, Inc. |
| 7 Nov 2019 | K192153 | Portux CAD/CAM Disc | New Stetic, SA |
| 4 Oct 2019 | K191843 | Ceramill A-Temp | Amann Girrbach AG |
| 11 Sep 2019 | K191619 | TurboTemp EZ | Zest Anchors, LLC |
| 5 Sep 2019 | K190930 | SmarTemp X1 | Parkell, Inc |
| 3 Jul 2019 | K190724 | MD-Temp Plus | Meta Biomed Co, Ltd |
| 29 May 2019 | K183337 | LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2 | DMG Chemisch-Pharmazeutische Fabrik GmbH |
| 13 Dec 2018 | K182065 | EVOLUX CAD/CAM PMMA BLOCKS | Blue Dent Dental |
| 12 Dec 2018 | K180578 | Harvest Dental Polymer Blocks | Harvest Dental Products, LLC |
| 7 Dec 2018 | K180657 | Resin for Temporary Crown & Bridge | Dentis Co., Ltd. |
| 28 Jun 2018 | K180562 | TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT | Zirkonzahn Srl |
| 13 Dec 2017 | K171729 | Fixtemp C&B | Dreve Dentamid GmbH |
| 19 Oct 2017 | K172281 | PuRE PMMA Disc | Quest Dental USA Corp. |
| 13 May 2016 | K153490 | DD medical polymers | Dental Direkt GmbH |
| 11 May 2016 | K152443 | Vericore Gradient Temporary Disc | Whip Mix Corporation |
| 12 Apr 2016 | K153753 | TelioCAD Multi | Ivoclar Vivadent, AG |
| 19 Jan 2016 | K152215 | DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR | Dentalplus GmbH |
| 23 Nov 2015 | K151764 | YAMAHACHI PMMA DISKS | Yamahachi Dental Products USA, Inc. |
| 14 Sep 2015 | K151144 | SuPro 100 | 3M Deutschland GmbH |
| 14 Aug 2015 | K150432 | IDODENTINE DISC, IDODENTINE BLOCK | Union Dental S.A. |
| 24 Apr 2015 | K142371 | Luminesse PMMA | Talladium, Inc. |
| 12 Feb 2015 | K133268 | TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR BLANK, TIZIAN BLANK OCCLUSAL, TIZIAN BLANK TRANS | Schutz Dental GmbH |
| 9 Feb 2015 | K141421 | PMMA BLOCK | Rizhao Huge Dental Industry Co., Ltd. |
| 5 Sep 2014 | K141562 | MSN-006 | GC America Inc. |
| 31 Jul 2014 | K140894 | ARGEN PMMA | The Argen Corporation |
| 21 May 2014 | K132937 | HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA) | Harvest Dental Products, LLC |
| 18 Dec 2013 | K131664 | COPRA TEMP PMMA-DISK | White Peaks Dental Systems GmbH & Co. KG |
| 21 Feb 2013 | K123638 | PEKKTON IVORY | Cendres & Metaux SA |
| 27 Dec 2012 | K122039 | KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B | Kettenbach GmbH & Co. KG |
| 9 Oct 2012 | K122025 | BRIGHTGLASS BRIGHTGLASS M | Ktk Medical Supplies GmbH |
| 28 Aug 2012 | K112967 | PMMA CAD/CAM DISC | Polident d.o.o. |
| 8 Jun 2012 | K120784 | TUFF-TEMP 2.0 | Pulpdent Corporation |
| 1 Jun 2012 | K120779 | STRUCTUR 3 | Voco GmbH |
| 8 Nov 2011 | K112186 | FIBER DISK AND BLOCK | Bioloren S.R.L. |
| 7 Sep 2011 | K111666 | EVADYNE TEMPORARY CROWN AND BRIDGE RESIN | Neodental Chemical Products Co., Ltd. |
| 17 Jun 2011 | K102917 | FIXTEMP C&B | Exacta Dental Direct, Inc. |
| 14 Jun 2011 | K110747 | TEMPFLEX | Sybron Dental Specialties |
| 25 May 2011 | K103514 | PRO-V COAT | Bisco, Inc. |
| 17 May 2011 | K110484 | SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL | Novocol, Inc. |
| 18 Feb 2011 | K102776 | EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM | Deltamed GmbH |
| 14 Feb 2011 | K103379 | TELIO CS INLAY & TELIO CS ONLAY | Ivoclar Vivadent, AG |
| 7 Feb 2011 | K103474 | ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT) | Micerium S.P.A. |
| 4 Feb 2011 | K102753 | TURBO TEMP 3 | Danville Materials, LLC |
| 16 Dec 2010 | K102341 | VIPI BLOCK | Vipi Industria,Comercio,Exportacao E Importacao DE |
| 28 Sep 2010 | K101710 | LUXATEMP ULTRA /STAR | Dmg USA, Inc. |
| 27 Sep 2010 | K101814 | DIRECT CROWN NATURAL 1 | Candulor USA, Inc. |
| 10 Mar 2010 | K093708 | TELIO CAD | Ivoclar Vivadent, AG |
| 5 Mar 2010 | K093380 | MIZZY EXPRESS | Mycone Dental Supply Co., Inc. |
| 23 Jul 2009 | K091894 | TEMPORARY C&B COMPOSITE | Voco GmbH |
| 5 Jun 2009 | K083195 | MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN | Lang Dental Mfg. Co., Inc. |
| 9 Dec 2008 | K082700 | TEMPORARY COLD.V AND SELF-CURE DENTINE | Major Prodotti Dentari S.P.A. |
| 17 Sep 2008 | K081810 | PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL | Pulpdent Corporation |
| 17 Sep 2008 | K081705 | LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESIN | Lang Dental Mfg. Co., Inc. |
| 2 May 2008 | K080556 | ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLEACH SHADES | Merz Dental GmbH |
| 18 Apr 2008 | K080311 | MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM | Dentsply Interntional |
| 11 Apr 2008 | K073106 | UNIFAST III | GC America Inc. |
| 8 Apr 2008 | K080182 | ZENO PMMA DISC | Wieland Dental + Technik GmbH & Co. KG |
| 14 Feb 2008 | K073263 | PRO-V | Bisco, Inc. |
| 9 Jan 2008 | K073296 | TEMPXN28 | 3M Espe AG Dental Products |
| 21 Aug 2007 | K071548 | WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLORED | Merz Dental GmbH |
| 1 Jun 2007 | K070991 | VITA CAD-TEMP FOR INLAB, MODEL, VX59-4002, VX59-4010, VX59-4102, VX59-4110, VX59-4202, VX59-4210, VX59-4302, VX59-4310 | Vita |
| 8 Feb 2007 | K063624 | KAVO EVEREST C-TEMP | Kavo America |
| 13 Sep 2006 | K061809 | ARTEGRAL IMCROWN | Merz Dental GmbH |
| 21 Jul 2006 | K061530 | MD-TEMP | Meta Biomed Co, Ltd |
| 23 May 2006 | K061264 | TEMPFX ESTHETIC PROVISIONAL SYSTEM | Dentsply International, Inc. |
| 16 May 2006 | K060881 | TEMPORARY CROWN & BRIDGE RESIN | Cosmedent, Inc. |
| 7 Mar 2006 | K052800 | PROVISIONAL INLAY/ONLAY KIT | Dmg USA, Inc. |
| 17 Feb 2006 | K060293 | TEMPORARY CROWN AND BRIDGE MATERIAL | Dentsply International, Inc. |
| 9 Dec 2005 | K052781 | BREFORMANCE | Bredent-Products For the Dental Technician Laborat |
| 14 Dec 2004 | K042820 | SYSTEMP.C&B PLUS | Ivoclar Vivadent, AG |
| 4 Aug 2004 | K041886 | PROVISO | Scientific Pharmaceuticals |
| 19 May 2004 | K040951 | SR ADORO | Ivoclar Vivadent, AG |
| 13 May 2004 | K041098 | COOL TEMP NATURAL | Coltene AG |
| 7 Apr 2004 | K040769 | STRUCTUR 2 SC | Voco GmbH |
| 16 Jan 2004 | K033227 | LUXAFORM PLUS | Dmg USA, Inc. |
| 15 Jan 2004 | K033432 | LEXATITE QUICK ACRYLIC | Imtec Corp. |
| 21 Nov 2003 | K033022 | PROTEMP 3 GARANT | 3M Espe AG Dental Products |
| 2 Jul 2003 | K031476 | FILL-IN | Sybron Dental Specialties |
| 21 Mar 2003 | K024282 | ACRYLIC | Inovativ, LLC |
| 30 Oct 2002 | K023079 | NEW OUTLINE | anax dent GmbH |
| 28 Aug 2002 | K022030 | POLY-CARB | Inovativ, LLC |
| 28 Aug 2002 | K013869 | SR IVOCRON | Ivoclar Vivadent, AG |
| 1 Aug 2002 | K021457 | FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL | Pentron Corp. |
| 15 Mar 2002 | K020178 | BELLEGLASS HP MODELING GEL | Kerr Dental Materials Center |
| 4 Mar 2002 | K020157 | TEMPORARY CROWN AND BRIDGE MATERIAL | J. Morita USA, Inc. |
| 22 Feb 2002 | K020092 | TEMPHASE | Kerr Dental Materials Center |
| 4 Feb 2002 | K013895 | TEMPFIL | Sybron Dental Specialties |
| 24 Jan 2002 | K013674 | LUXATEMP/LUXATEMP SOLAR/INSTATEMP | Dmg USA, Inc. |
| 6 Sep 2001 | K012360 | LC TEMPORARY FILLING | Parkell, Inc |
| 14 Feb 2001 | K010012 | LC PROVIFILL | S & C Polymer GmbH |
| 16 Jan 2001 | K003817 | PATTERN RESIN | GC America Inc. |
| 4 Dec 2000 | K003377 | FERMIT N PLUS | Ivoclar North America, Inc. |
| 4 Dec 2000 | K003374 | FERMIT PLUS | Ivoclar North America, Inc. |
| 25 Oct 2000 | K001884 | DIRECT CROWN | Flexible Dimensions, LLC |
| 10 Aug 2000 | K002364 | PROTEMP H | Espe Dental AG |
| 13 Jun 2000 | K001309 | HYDRO-CAST BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MODEL 98250 | Kay See Dental Mfg. Co. |
| 9 Jun 2000 | K001114 | 3M QUIK TEMP TEMPORIZATION MATERIAL | 3M Company |
| 19 May 2000 | K000894 | C&B RESIN PLUS POWDER/LIQUID, MODELS RETEMP A2, A3, A3.5, CL, RETEMP B2, B3, C2, D3, WH, RETEMP MO | Dental Ventures of America, Inc. |
| 14 Apr 2000 | K000346 | EZ CONNECT | Kerr Dental Materials Center |
| 5 Apr 2000 | K000951 | LUXAFORM | Dmg USA, Inc. |
| 16 Feb 2000 | K994012 | TEMPOFIT, MODEL 02693 | Detax GmbH & Co. KG |
| 23 Jun 1999 | K991564 | JELTEMP | J.F. Jelenko & Co., Inc. |
| 21 May 1999 | K991270 | SMARTEMP | Parkell, Inc |
| 28 Oct 1998 | K980799 | HIGH VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL | Cosmedent, Inc. |
| 30 Sep 1998 | K982459 | TEMPFIL F - 2 | Sybron Dental Specialties |
| 17 Dec 1997 | K972198 | DENT-TEMP ACRYLIC | Health-Dent Intl., Inc. |
| 27 Feb 1997 | K970168 | 3M QUIKPLUS SYSTEM | 3M Company |
| 10 Feb 1997 | K964981 | TEMPFIL C&B | Sybron Dental Specialties |
| 4 Feb 1997 | K964691 | TCB TEMPORARY CROWN AND BRIDGE MATERIAL | Coltene/Whaledent AG |
| 19 Nov 1996 | K963786 | TEMPFIL F | Sybron Dental Specialties |
| 25 Jun 1996 | K961199 | BOSWORTH TEMPORARY RESIN | Harry J. Bosworth Co. |
| 24 May 1996 | K961198 | BOSWORTH CH I | Harry J. Bosworth Co. |
| 25 Apr 1996 | K954976 | POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATION) | Healex Products, Inc. |
| 18 Apr 1996 | K960938 | PROV-KB | Silicon-Und Composite Spezialitaten GmbH |
| 21 Feb 1996 | K960122 | ALPHA-DENT TEMPORARY CROWN AND BRIDGE MATERIAL | Wallace A. Erickson & Co. |
| 2 Jan 1996 | K955331 | BELLEGLASHP | Sybron Dental Specialties |
| 2 Feb 1995 | K950203 | PROTEMP(R) GARANT | Espe GmbH & Co. Kg. |
| 2 Dec 1994 | K944981 | 3M TEMPCARE LIGHT CURE TEMPORARY SYSTEM | 3M Company |
| 18 Oct 1994 | K942670 | GC PATTERN RESIN | GC America Inc. |
| 17 Aug 1994 | K941849 | PROVIPONT C&B | Ivoclar USA, Inc. |
| 29 Apr 1994 | K924830 | LUXATEMP AUTOMIX | DMG Chemisch-Pharmazeutische Fabrik GmbH |
| 13 Apr 1994 | K941124 | STRUCTUR 2 | Voco GmbH |
| 4 Mar 1994 | K935960 | GC TEMPRON | GC America Inc. |
| 26 Jan 1994 | K935041 | 3M TEMPORARY CROWN & BRIDGE MATERIAL | 3M Company |
| 10 Dec 1993 | K934978 | FERMIT N LIGHT-CURING TEMPORARY FILLING MATERIAL | Ivoclar North America, Inc. |
| 10 Dec 1993 | K934283 | DENTALON PLUS MODIFICATION | Heraeus Kulzer, LLC |
| 6 Aug 1993 | K932034 | PALAVIT 55 AND DENTACOLOR CONNECTOR | Heraeus Kulzer, LLC |
| 24 Dec 1992 | K922559 | ACUFEX ENDOFIX BUTTON | Acufex Microsurgical, Inc. |
| 3 Feb 1992 | K915466 | SEPTOPACK TEMPORARY FILLING | Specialites Septodont |
| 6 Jun 1991 | K904251 | NEW TRIAD VLC CROWN & BRIDGE PROVISIONAL MATERIAL | Dentifax Intern, Inc. |
| 13 Aug 1990 | K903317 | DENTALON PLUS | Kulzer, LLC |
| 13 Jul 1990 | K900389 | TEMPORARY CROWN MATRIX BUTTONS | Advantage Dental Products, Inc. |
| 29 May 1990 | K901077 | PRELUDE (TEMPORARY CROWN AND BRIDGE CEMENT) | Scientific Pharmaceuticals |
| 3 Apr 1990 | K900068 | ARISTEE (RESIN, CROWN AND BRIDGES) | Prometex, Inc. |
| 28 Mar 1990 | K900436 | PROTEMP II | Espe GmbH (Us) |
| 24 Oct 1989 | K892710 | ARISTEE (TEMPORARY CROWN & BRIDGE RESIN) | Prometex, Inc. |
| 17 Apr 1989 | K890829 | UNIFAST LC | G-C Intl. Corp. |
| 1 Mar 1988 | K875133 | CAVIT-W | Espe GmbH (Us) |
| 26 Feb 1988 | K875145 | MAR BOND | Reliance Orthodontic Products, Inc. |
| 3 Apr 1986 | K853092 | PSP C & B TEMP | Psp Dental Co., Ltd. |
| 16 Aug 1985 | K853052 | INTEGRITY | Dentsply Intl., Inc. |
| 3 Jan 1984 | K833261 | INTERIM TEMP. CROWN & BRIDGE RESIN | Coe Laboratories, Inc. |
| 12 Sep 1983 | K831077 | DENTALON | Kulzer, LLC |
| 31 Aug 1983 | K831294 | SOLARCRY/TEMPORARY CROWN & BRIDGE MAT | Solar Dental Co., Inc. |
| 30 Sep 1982 | K822722 | CROWN S BRIDGE RESIN | Rohm and Haas Co. |
| 28 Sep 1982 | K822452 | PROTEMP | Espe GmbH (Us) |
| 19 Mar 1982 | K820456 | CROWN & BRIDGE RESIN FOR FABRICAT/DE | Rohm and Haas Co. |
| 17 Dec 1980 | K802679 | SILANIT | Vivadent (Usa), Inc. |
| 12 Nov 1980 | K802489 | REIGNING CROWN BRIDGE | Oki Shiks USA , Ltd. |
| 29 Apr 1980 | K800828 | MYERSON'S SPECIAL CROWN & BRIDGE RESIN | Myerson Tooth Corp. |
| 31 Aug 1978 | K781244 | TEMP. CROWN MSTERIAL FOR TEETH | Den-Mat Corp. |
| 22 Dec 1977 | K772211 | TEMP. ACRYLIC | Lactong Corp. |
| 30 Aug 1977 | K771602 | MYERSONS SPEC. CROWN & BRIDGE RESIN | Howmedica Corp. |
| 25 Aug 1977 | K771530 | TEMP. CROWN ACRYLIC RESIN | J. Palmero Sales Co., Inc. |
| 16 Aug 1977 | K771527 | ACCU. CROWN COLD CURE | Parker Laboratories, Inc. |
| 15 Jul 1977 | K771257 | ACRY TEMP | Interstate Dental Co., Inc. |
| 15 Jul 1977 | K771254 | ACCU. CROWN COLD CURE | Briar Cliff, Inc. |
Official records: FDA product classification for EBG · 21 CFR 872.3770.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026