FDA Product Code
FDA Product Code EBG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3770
510(k) Clearances — 189 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261261 | Dura-Arch | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-04-17 | Traditional | PDF ↗ |
| K253380 | FLNT Base and FLNT Temp | Liaoning Upcera Co., Ltd. | 2026-03-02 | Traditional | PDF ↗ |
| K251271 | TempFIT Temporary Crown and Bridge Resin | Rizhao Huge Biomaterials Company, Ltd. | 2025-06-23 | Traditional | PDF ↗ |
| K243370 | DentaTOOTH | Asiga Pty, Ltd. | 2025-05-05 | Traditional | PDF ↗ |
| K243621 | Evoblock, Perléon | Evoden Indústria Comércio Importação E Exportação | 2025-04-22 | Traditional | PDF ↗ |
| K243951 | TEMP MASTER, PMMA-based dental resin | Taiwan Dental Materials Co., Ltd. | 2025-02-21 | Traditional | PDF ↗ |
| K231859 | PrimmaArt | Dentscare Ltda | 2024-11-26 | Traditional | PDF ↗ |
| K242559 | Digital Temp | Sprintray, Inc. | 2024-11-26 | Traditional | PDF ↗ |
| K240538 | Premium Teeth Resin | Formlabs Ohio, Inc. | 2024-07-19 | Traditional | PDF ↗ |
| K241226 | Fixtemp® C&B 4:1 | Dreve Denatmid GmbH | 2024-05-31 | Special | PDF ↗ |
| K233868 | dima Print Teeth & Temp | Kulzer, LLC | 2024-05-23 | Traditional | PDF ↗ |
| K223706 | PMMA BLOCK | Huliang(Shanghai) Bio-Tech Co., Ltd. | 2023-05-12 | Traditional | PDF ↗ |
| K223477 | PMMA Blocks for Dental Use | Aidite (Qinhuangdao) Technology Co., Ltd. | 2023-02-16 | Traditional | PDF ↗ |
| K202965 | CURA-Temp | Mgnewton , Ltd. | 2022-12-21 | Traditional | PDF ↗ |
| K214071 | Hexa-Temp | Spident Co., Ltd. | 2022-03-10 | Traditional | PDF ↗ |
| K213643 | UltraPrint-Dental Temp C&B UV | Guangzhou Heygears IMC., Inc. | 2022-01-14 | Traditional | PDF ↗ |
| K210817 | C&B 5.0 Hybrid | Arum Dentistry Co., Ltd. | 2021-12-08 | Traditional | PDF ↗ |
| K211101 | E-Temp | Envisiontec GmbH | 2021-06-14 | Traditional | PDF ↗ |
| K201563 | PuRE PMMA Disc | Quest Dental USA Corp. | 2021-04-09 | Special | PDF ↗ |
| K190217 | Aidite PMMA | Aidite (Qinhuangdao) Technology Co., Ltd. | 2020-12-17 | Traditional | PDF ↗ |
| K201827 | GR-17 Resin System | Pro3Dure Medical GmbH | 2020-11-05 | Traditional | PDF ↗ |
| K201683 | PMMA Block | Huge Dental Material Co., Ltd. | 2020-11-03 | Traditional | PDF ↗ |
| K200273 | FREEPRINT temp | Detax GmbH & Co. KG | 2020-10-27 | Traditional | PDF ↗ |
| K201090 | Structur CAD | Voco GmbH | 2020-09-09 | Traditional | PDF ↗ |
| K192830 | Bright Temporary C&B | Dmp Dental Industry S.A. | 2020-09-02 | Traditional | PDF ↗ |
| K200039 | P pro Crown & Bridge | Deltamed GmbH | 2020-07-31 | Traditional | PDF ↗ |
| K193113 | GC Temp Print | GC America, Inc. | 2020-07-09 | Traditional | PDF ↗ |
| K200676 | ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA | Zirkonzahn Srl | 2020-07-08 | Traditional | PDF ↗ |
| K193553 | VarseoSmile Temp | Bego Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG | 2020-05-18 | Traditional | PDF ↗ |
| K191590 | AA temp temporary restoration 3D printing photoreactive resin | Enlighten Materials Co., Ltd. | 2020-05-05 | Traditional | PDF ↗ |
| K192022 | DiaTemp Flow | DiaDent Group International | 2020-02-13 | Traditional | PDF ↗ |
| K192158 | DiaTemp | DiaDent Group International | 2020-02-13 | Traditional | PDF ↗ |
| K192806 | DENTCA Crown and Bridge | Dentca, Inc. | 2020-02-05 | Traditional | PDF ↗ |
| K192153 | Portux CAD/CAM Disc | New Stetic, SA | 2019-11-07 | Traditional | PDF ↗ |
| K191843 | Ceramill A-Temp | Amann Girrbach AG | 2019-10-04 | Traditional | PDF ↗ |
| K191619 | TurboTemp EZ | Zest Anchors, LLC | 2019-09-11 | Traditional | PDF ↗ |
| K190930 | SmarTemp X1 | Parkell, Inc. | 2019-09-05 | Traditional | PDF ↗ |
| K190724 | MD-Temp Plus | Meta Biomed Co., Ltd. | 2019-07-03 | Traditional | PDF ↗ |
| K183337 | LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2 | DMG Chemisch-Pharmazeutische Fabrik GmbH | 2019-05-29 | Traditional | PDF ↗ |
| K182065 | EVOLUX CAD/CAM PMMA BLOCKS | Blue Dent Dental | 2018-12-13 | Traditional | PDF ↗ |
| K180578 | Harvest Dental Polymer Blocks | Harvest Dental Products, LLC | 2018-12-12 | Traditional | PDF ↗ |
| K180657 | Resin for Temporary Crown & Bridge | Dentis Co., Ltd. | 2018-12-07 | Traditional | PDF ↗ |
| K180562 | TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT | Zirkonzahn GmbH | 2018-06-28 | Traditional | PDF ↗ |
| K171729 | Fixtemp C&B | Dreve Dentamid GmbH | 2017-12-13 | Traditional | PDF ↗ |
| K172281 | PuRE PMMA Disc | Quest Dental USA Corp. | 2017-10-19 | Traditional | PDF ↗ |
| K153490 | DD medical polymers | Dental Direkt GmbH | 2016-05-13 | Traditional | PDF ↗ |
| K152443 | Vericore Gradient Temporary Disc | Whip Mix Corporation | 2016-05-11 | Traditional | PDF ↗ |
| K153753 | TelioCAD Multi | Ivoclar Vivadent, Inc. | 2016-04-12 | Traditional | PDF ↗ |
| K152215 | DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR | Dentalplus GmbH | 2016-01-19 | Traditional | PDF ↗ |
| K151764 | YAMAHACHI PMMA DISKS | Yamahachi Dental Products USA, Inc. | 2015-11-23 | Traditional | PDF ↗ |
| K151144 | SuPro 100 | 3M Deutschland GmbH | 2015-09-14 | Traditional | PDF ↗ |
| K150432 | IDODENTINE DISC, IDODENTINE BLOCK | Union Dental S.A. | 2015-08-14 | Traditional | PDF ↗ |
| K142371 | Luminesse PMMA | Talladium, Inc. | 2015-04-24 | Traditional | PDF ↗ |
| K133268 | TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR BLANK, TIZIAN BLANK OCCLUSAL, TIZIAN BLANK TRANS | Schutz-Dental GmbH | 2015-02-12 | Traditional | PDF ↗ |
| K141421 | PMMA BLOCK | Rizhao Huge Dental Industry Co., Ltd. | 2015-02-09 | Abbreviated | PDF ↗ |
| K141562 | MSN-006 | GC America, Inc. | 2014-09-05 | Traditional | PDF ↗ |
| K140894 | ARGEN PMMA | The Argen Corporation | 2014-07-31 | Traditional | PDF ↗ |
| K132937 | HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA) | Harvest Dental Products, LLC | 2014-05-21 | Traditional | PDF ↗ |
| K131664 | COPRA TEMP PMMA-DISK | White Peaks Dental Systems GmbH & Co. KG | 2013-12-18 | Traditional | PDF ↗ |
| K123638 | PEKKTON IVORY | Cendres & Metaux SA | 2013-02-21 | Traditional | PDF ↗ |
| K122039 | KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B | Kettenbach GmbH & Co. KG | 2012-12-27 | Traditional | PDF ↗ |
| K122025 | BRIGHTGLASS BRIGHTGLASS M | Ktk Medical Supplies GmbH | 2012-10-09 | Traditional | PDF ↗ |
| K112967 | PMMA CAD/CAM DISC | Polident D.O.O., Dental Products Industry | 2012-08-28 | Traditional | PDF ↗ |
| K120784 | TUFF-TEMP 2.0 | Pulpdent Corporation | 2012-06-08 | Traditional | PDF ↗ |
| K120779 | STRUCTUR 3 | Voco GmbH | 2012-06-01 | Traditional | PDF ↗ |
| K112186 | FIBER DISK AND BLOCK | Bioloren S.R.L. | 2011-11-08 | Traditional | PDF ↗ |
| K111666 | EVADYNE TEMPORARY CROWN AND BRIDGE RESIN | Neodental Chemical Products Co., Ltd. | 2011-09-07 | Traditional | PDF ↗ |
| K102917 | FIXTEMP C&B | Exacta Dental Direct, Inc. | 2011-06-17 | Traditional | PDF ↗ |
| K110747 | TEMPFLEX | Kerr Corporation | 2011-06-14 | Traditional | PDF ↗ |
| K103514 | PRO-V COAT | Bisco, Inc. | 2011-05-25 | Traditional | PDF ↗ |
| K110484 | SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL | Novocol, Inc. | 2011-05-17 | Traditional | PDF ↗ |
| K102776 | EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM | Deltamed GmbH | 2011-02-18 | Traditional | PDF ↗ |
| K103379 | TELIO CS INLAY & TELIO CS ONLAY | Ivoclar Vivadent, Inc. | 2011-02-14 | Traditional | PDF ↗ |
| K103474 | ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT) | Micerium S.P.A. | 2011-02-07 | Traditional | PDF ↗ |
| K102753 | TURBO TEMP 3 | Danville Materials, Inc. | 2011-02-04 | Traditional | PDF ↗ |
| K102341 | VIPI BLOCK | Vipi Industria,Comercio,Exportacao E Importacao DE | 2010-12-16 | Traditional | PDF ↗ |
| K101710 | LUXATEMP ULTRA /STAR | Dmg USA, Inc. | 2010-09-28 | Abbreviated | PDF ↗ |
| K101814 | DIRECT CROWN NATURAL 1 | Candulor USA, Inc. | 2010-09-27 | Traditional | PDF ↗ |
| K093708 | TELIO CAD | Ivoclar Vivadent, Inc. | 2010-03-10 | Traditional | PDF ↗ |
| K093380 | MIZZY EXPRESS | Mycone Dental Supply Co., Inc. | 2010-03-05 | Traditional | PDF ↗ |
| K091894 | TEMPORARY C&B COMPOSITE | Voco GmbH | 2009-07-23 | Special | PDF ↗ |
| K083195 | MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN | Lang Dental Mfg. Co., Inc. | 2009-06-05 | Traditional | PDF ↗ |
| K082700 | TEMPORARY COLD.V AND SELF-CURE DENTINE | Major Prodotti Dentari S.P.A. | 2008-12-09 | Abbreviated | PDF ↗ |
| K081705 | LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESIN | Lang Dental Mfg. Co., Inc. | 2008-09-17 | Traditional | PDF ↗ |
| K081810 | PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL | Pulpdent Corporation | 2008-09-17 | Traditional | PDF ↗ |
| K080556 | ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLEACH SHADES | Merz Dental GmbH | 2008-05-02 | Traditional | PDF ↗ |
| K080311 | MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM | Dentsply Interntional | 2008-04-18 | Traditional | PDF ↗ |
| K073106 | UNIFAST III | GC America, Inc. | 2008-04-11 | Traditional | PDF ↗ |
| K080182 | ZENO PMMA DISC | Wieland Dental + Technik GmbH & Co. KG | 2008-04-08 | Traditional | PDF ↗ |
| K073263 | PRO-V | Bisco, Inc. | 2008-02-14 | Traditional | PDF ↗ |
| K073296 | TEMPXN28 | 3M Espe AG Dental Products | 2008-01-09 | Traditional | PDF ↗ |
| K071548 | WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLORED | Merz Dental GmbH | 2007-08-21 | Traditional | PDF ↗ |
| K070991 | VITA CAD-TEMP FOR INLAB, MODEL, VX59-4002, VX59-4010, VX59-4102, VX59-4110, VX59-4202, VX59-4210, VX59-4302, VX59-4310 | Vita | 2007-06-01 | Traditional | PDF ↗ |
| K063624 | KAVO EVEREST C-TEMP | Kavo America | 2007-02-08 | Traditional | PDF ↗ |
| K061809 | ARTEGRAL IMCROWN | Merz Dental GmbH | 2006-09-13 | Traditional | PDF ↗ |
| K061530 | MD-TEMP | Meta Biomed Co., Ltd. | 2006-07-21 | Traditional | PDF ↗ |
| K061264 | TEMPFX ESTHETIC PROVISIONAL SYSTEM | Dentsply International, Inc. | 2006-05-23 | Special | PDF ↗ |
| K060881 | TEMPORARY CROWN & BRIDGE RESIN | Cosmedent, Inc. | 2006-05-16 | Traditional | PDF ↗ |
| K052800 | PROVISIONAL INLAY/ONLAY KIT | Dmg USA, Inc. | 2006-03-07 | Abbreviated | PDF ↗ |
| K060293 | TEMPORARY CROWN AND BRIDGE MATERIAL | Dentsply International, Inc. | 2006-02-17 | Traditional | PDF ↗ |
Product code EBG · Class II · Dental. Data: openFDA.