Data / Medical devices / Powder, Porcelain
Powder, Porcelain (EIH): 116 FDA-registered makers in 17 countries
116 establishments in 17 countries are registered with the FDA to make Powder, Porcelain (product code EIH, Class 2, 21 CFR 872.6660). 100 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 489 510(k) clearances under this code, the latest on October 21, 2026, and lists 7 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- EIH
- Device class
- 2
- Regulation
- 872.6660
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| China | 31 |
| United States | 30 |
| South Korea | 16 |
| Germany | 12 |
| Japan | 8 |
| Liechtenstein | 4 |
| Austria | 2 |
| Switzerland | 2 |
| Italy | 2 |
| Philippines | 2 |
| Canada | 1 |
| Belgium | 1 |
| Taiwan | 1 |
| United Kingdom | 1 |
| Hungary | 1 |
| Sweden | 1 |
| Vietnam | 1 |
Makers of Powder, Porcelain
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Vita Zahnfabrik H. Rauter GMBH & Co. KG. | BAD SACKINGEN Baden-Wurttemberg, Germany | Manufacturer, Repackager or relabeler | 25 | February 21, 2025 | 0 | 0 | 0 | api.fda.gov |
| Kuraray Noritake Dental Inc. Miyoshi Plant | MIYOSHI Aichi, Japan | Manufacturer | 18 | May 29, 2025 | 0 | 0 | 0 | api.fda.gov |
| Prismatik Dentalcraft, Inc. | Irvine, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 18 | July 30, 2026 | 0 | 1 | 0 | api.fda.gov |
| Degudent GMBH | HANAU Hesse, Germany | Exporter to the US, Manufacturer, Specification developer | 14 | October 24, 2024 | 0 | 0 | 0 | api.fda.gov |
| Ivoclar Vivadent AG | Schaan, Liechtenstein | Manufacturer, Specification developer | 14 | March 10, 2026 | 0 | 1 | 0 | api.fda.gov |
| Shofu Inc. | FUKUINE, HIGASHIYAMA-KU Kyoto, Japan | Manufacturer | 14 | March 18, 2022 | 0 | 0 | 0 | api.fda.gov |
| Klema Dentalprodukte GMBH | Meiningen Vorarlberg, Austria | Complaint file establishment, Manufacturer | 11 | March 25, 2016 | 0 | 0 | 0 | api.fda.gov |
| GENOSS Co., Ltd. | Suwon-si Gyeonggi, South Korea | Manufacturer | 10 | June 21, 2024 | 0 | 0 | 0 | api.fda.gov |
| Institut Straumann AG | BASEL Basel-Stadt, Switzerland | Complaint file establishment, Exporter to the US, Specification developer | 8 | November 14, 2017 | 0 | 0 | 0 | api.fda.gov |
| Amann Girrbach AG | Maeder Vorarlberg, Austria | Exporter to the US, Manufacturer | 7 | June 29, 2026 | 0 | 0 | 0 | api.fda.gov |
| Dental Direkt GmbH | Spenge North Rhine-Westphalia, Germany | Contract manufacturer, Manufacturer, Repackager or relabeler | 7 | September 6, 2024 | 0 | 0 | 0 | api.fda.gov |
| GC America Inc. | Alsip, IL, United States | Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler | 7 | February 3, 2017 | 0 | 0 | 0 | api.fda.gov |
| Liaoning Upcera Co.,Ltd | Benxi Liaoning, China | Manufacturer | 7 | January 9, 2026 | 0 | 0 | 0 | api.fda.gov |
| Aidite (qinhuangdao) Technology Co., Ltd | Qinhuangdao City Hebei, China | Manufacturer | 6 | May 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| Dentsply LLC | York, PA, United States | Specification developer | 6 | August 12, 2016 | 0 | 0 | 0 | api.fda.gov |
| Jensen Industries, Inc. | North Haven, CT, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 6 | March 20, 2019 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Xiangtong Co., Ltd. | Dongguan Guangdong, China | Manufacturer | 6 | December 8, 2025 | 0 | 0 | 0 | api.fda.gov |
| Zirkonzahn SRL | Gais Bolzano, Italy | Contract manufacturer, Manufacturer | 6 | December 14, 2022 | 0 | 0 | 0 | api.fda.gov |
| etkon GMBH | Markkleeberg Saxony, Germany | Manufacturer | 6 | November 14, 2017 | 0 | 0 | 0 | api.fda.gov |
| Talladium, Inc. | Santa Clarita, CA, United States | Manufacturer | 5 | September 15, 2016 | 0 | 1 | 0 | api.fda.gov |
| The Argen Corporation | San Diego, CA, United States | Manufacturer, Manufacturer for export, Repackager or relabeler | 5 | October 24, 2024 | 0 | 0 | 0 | api.fda.gov |
| The Argen Corporation | San Diego, CA, United States | Complaint file establishment, Manufacturer, Manufacturer for export | 5 | October 24, 2024 | 0 | 0 | 0 | api.fda.gov |
| Vatech mcis Co., Ltd. | Suwon-si Gyeonggi, South Korea | Manufacturer | 5 | June 20, 2023 | 0 | 0 | 0 | api.fda.gov |
| Chengdu Besmile Medical Technology Co., Ltd. | Chengdu Sichuan, China | Exporter to the US, Manufacturer | 4 | March 19, 2024 | 0 | 0 | 0 | api.fda.gov |
| DENTAL LABORATORY MILLING SUPPLIES LLC (DLMS) / Digital Dental | Scottsdale, AZ, United States | Specification developer | 4 | May 6, 2015 | 0 | 0 | 0 | api.fda.gov |
| Imagine Milling Technologies, LLC | Chantilly, VA, United States | Contract manufacturer, Remanufacturer, Repackager or relabeler, Specification developer | 4 | February 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| Sagemax Bioceramics, Inc. | Federal Way, WA, United States | Specification developer | 4 | December 16, 2015 | 0 | 1 | 0 | api.fda.gov |
| ARUM DENTISTRY Co., Ltd. | Yuseong-gu Daejeon, South Korea | Manufacturer | 3 | July 10, 2025 | 0 | 0 | 0 | api.fda.gov |
| Dentalmax Co., Ltd | Cheonan-si Chungnam, South Korea | Manufacturer | 3 | September 30, 2024 | 0 | 0 | 0 | api.fda.gov |
| DMAX Co., Ltd. | Daegu, South Korea | Contract manufacturer, Manufacturer | 3 | June 12, 2025 | 0 | 0 | 0 | api.fda.gov |
| GC Dental Products Corp. | KASUGAI-SHI Aichi, Japan | Manufacturer | 3 | August 9, 2007 | 0 | 0 | 0 | api.fda.gov |
| Hass Corp. | Gangneung-si Gangwon, South Korea | Manufacturer | 3 | June 11, 2026 | 0 | 0 | 0 | api.fda.gov |
| Hass Corp. | Gangneung-si Gangwon, South Korea | Manufacturer | 3 | June 11, 2026 | 0 | 0 | 0 | api.fda.gov |
| Hunan Vsmile Biotechnology Co.,ltd | Changsha Hunan, China | Exporter to the US, Manufacturer, Repackager or relabeler | 3 | November 13, 2024 | 0 | 0 | 0 | api.fda.gov |
| Pritidenta GMBH | Leinfelden-Echterdingen Baden-Wurttemberg, Germany | Exporter to the US, Foreign private label distributor, Manufacturer | 3 | February 3, 2017 | 0 | 0 | 0 | api.fda.gov |
| Proto3000 Inc. | Vaughan Ontario, Canada | Manufacturer | 3 | April 16, 2020 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Yurucheng Dental Materials Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 3 | December 21, 2023 | 0 | 0 | 0 | api.fda.gov |
| Sirona Dental Systems GMBH | BENSHEIM Hesse, Germany | Exporter to the US, Specification developer | 3 | August 1, 2018 | 0 | 0 | 0 | api.fda.gov |
| Solventum Germany GmbH | SEEFELD Bavaria, Germany | Manufacturer | 3 | September 1, 2016 | 0 | 0 | 0 | api.fda.gov |
| United Dental Resources Corporation | University Park, IL, United States | Manufacturer | 3 | February 23, 2021 | 0 | 0 | 0 | api.fda.gov |
| Yilink (Tianjin) Biotechnology Co., Ltd. | Tianjin, China | Manufacturer | 3 | October 10, 2024 | 0 | 0 | 0 | api.fda.gov |
| Bloomden Bioceramics (hunan) Co.,ltd. | Changsha Hunan, China | Manufacturer | 2 | March 30, 2026 | 0 | 0 | 0 | api.fda.gov |
| Deprag High Tech Materials ( Zhengzhou ) Co.,ltd. | ZHANGZHOU Henan, China | Manufacturer | 2 | July 3, 2023 | 0 | 0 | 0 | api.fda.gov |
| Dentaurum GmbH & Co. KG | ISPRINGEN Baden-Wurttemberg, Germany | Manufacturer | 2 | June 5, 2001 | 0 | 0 | 0 | api.fda.gov |
| Estetic Ceram AG | Triesen, Liechtenstein | Contract manufacturer, Manufacturer | 2 | June 5, 2025 | 0 | 0 | 0 | api.fda.gov |
| GC Corp. | ITABASHI-KU Tokyo, Japan | Complaint file establishment, Manufacturer | 2 | September 13, 2016 | 0 | 0 | 0 | api.fda.gov |
| GC Corporation-Fuji Oyama Factory | SUNTO-GUN, Shizuoka-Ken, Japan | Complaint file establishment, Manufacturer | 2 | September 13, 2016 | 0 | 0 | 0 | api.fda.gov |
| GC Europe N.V. | LEUVEN Vlaams Brabant, Belgium | Manufacturer, Repackager or relabeler | 2 | November 26, 2008 | 0 | 0 | 0 | api.fda.gov |
| Ids Korea | Seoul, South Korea | Manufacturer | 2 | October 11, 2019 | 0 | 0 | 0 | api.fda.gov |
| Osstem Implant Co., Ltd. | Gangseo-gu Seoul, South Korea | Specification developer | 2 | November 20, 2024 | 0 | 0 | 0 | api.fda.gov |
| Osstem Implant Co., Ltd. | SIHEUNG Gyeonggi, South Korea | Manufacturer | 2 | November 20, 2024 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Up3d Tech Co., Ltd. | Shenzhen Guangdong, China | Manufacturer, Repackager or relabeler | 2 | May 25, 2023 | 0 | 0 | 0 | api.fda.gov |
| Shandong Huge Dental Material Corporation | Rizhao Shandong, China | Manufacturer | 2 | April 9, 2026 | 0 | 0 | 0 | api.fda.gov |
| Whitepeaks Dental Solutions GMBH | Hamminkeln North Rhine-Westphalia, Germany | Manufacturer | 2 | February 21, 2013 | 0 | 0 | 0 | api.fda.gov |
| Amsusa LLC | Atlanta, GA, United States | Manufacturer, Specification developer | 1 | May 4, 2017 | 0 | 0 | 0 | api.fda.gov |
| Anhui Miisen Intelligence Technology Co., Ltd. | Wuhu Anhui, China | Exporter to the US, Manufacturer | 1 | May 31, 2024 | 0 | 0 | 0 | api.fda.gov |
| B And D Dental Corporation | West Valley City, UT, United States | Manufacturer | 1 | August 11, 2011 | 0 | 0 | 0 | api.fda.gov |
| Baot Biological Technology Co., Ltd. | Zhongshan Guangdong, China | Exporter to the US, Manufacturer | 1 | May 22, 2019 | 0 | 0 | 0 | api.fda.gov |
| Bisco, Inc. | Schaumburg, IL, United States | Contract manufacturer, Manufacturer | 1 | March 31, 1993 | 0 | 0 | 0 | api.fda.gov |
| BMF Precision, Inc. | Maynard, MA, United States | Complaint file establishment, Specification developer | 1 | April 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Cendres+metaux SA | Biel/Bienne Bern, Switzerland | Specification developer | 1 | January 15, 2020 | 0 | 0 | 0 | api.fda.gov |
| Ceragroup Industries | Fort Lauderdale, FL, United States | Contract manufacturer, Manufacturer | 1 | August 26, 2000 | 0 | 0 | 0 | api.fda.gov |
| Changsha Honchon Technology Co., Ltd | Changsha Hunan, China | Manufacturer | 1 | July 8, 2022 | 0 | 0 | 0 | api.fda.gov |
| COHO Advanced Materials Tech. Co., Ltd. | Luzhu District Taoyuan, Taiwan | Manufacturer | 1 | June 17, 2015 | 0 | 0 | 0 | api.fda.gov |
| Creamed GMBH & Co. Produktions- Und Handels KG | Marburg Hesse, Germany | Manufacturer | 1 | September 24, 2013 | 0 | 0 | 0 | api.fda.gov |
| Davis Schottlander & Davis, Ltd. | LETCHWORTH, HERTS. Hertfordshire, United Kingdom | Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer | 1 | August 25, 2003 | 0 | 0 | 0 | api.fda.gov |
| De Corematrix Co.ltd. | Jiujiang Jiangxi, China | Manufacturer | 1 | May 29, 2020 | 0 | 0 | 0 | api.fda.gov |
| Den-Mat Holdings, LLC | Lompoc, CA, United States | Complaint file establishment, Manufacturer | 1 | August 25, 2025 | 0 | 0 | 0 | api.fda.gov |
| DENKEN-HIGHDENTAL Co., Ltd. | Kyoto, Japan | Complaint file establishment, Manufacturer | 1 | July 14, 2022 | 0 | 0 | 0 | api.fda.gov |
| DENTSPLY IH Inc. | Waltham, MA, United States | Manufacturer | 1 | January 29, 2016 | 0 | 0 | 0 | api.fda.gov |
| Doctus Global | Goyang-si, Gyeonggi-do, South Korea | Manufacturer | 1 | June 30, 2023 | 0 | 0 | 0 | api.fda.gov |
| Fuzhou Rick Brown Biomaterials Co. Ltd. | Fuzhou Fujian, China | Manufacturer | 1 | July 3, 2023 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou Ivista Medical Devices Co., Ltd | Hangzhou Zhejiang, China | Manufacturer | 1 | January 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Hiossen, Inc. | Morrisville, PA, United States | Manufacturer | 1 | October 31, 2018 | 0 | 0 | 0 | api.fda.gov |
| Hunan Ceramaster Material Technology Co., Ltd | Changsha Hunan, China | Manufacturer | 1 | May 20, 2024 | 0 | 0 | 0 | api.fda.gov |
| Hunan Hualian Special Ceramics Co., Ltd | Zhuzhou Hunan, China | Exporter to the US, Manufacturer | 1 | July 9, 2024 | 0 | 0 | 0 | api.fda.gov |
| Hunan Qinghaopuzhong Technology Co., Ltd. | Zhuzhou Hunan, China | Manufacturer | 1 | August 30, 2024 | 0 | 0 | 0 | api.fda.gov |
| Kerox KFT. | Soskut Pest, Hungary | Manufacturer | 1 | June 6, 2012 | 0 | 0 | 0 | api.fda.gov |
| Keystone Industries - Gibbstown | Gibbstown, NJ, United States | Contract manufacturer, Manufacturer | 1 | March 27, 2003 | 0 | 0 | 0 | api.fda.gov |
| Liaoning Rachcera Material Technology Co.,ltd. | Shenyang Liaoning, China | Manufacturer | 1 | December 5, 2024 | 0 | 0 | 0 | api.fda.gov |
| Mediclus Co., Ltd | Cheongju-si Chungbuk, South Korea | Manufacturer | 1 | August 21, 2026 | 0 | 0 | 0 | api.fda.gov |
| Monde Dental Lab | Shenzhen Guangdong, China | Manufacturer | 1 | July 6, 2009 | 0 | 0 | 0 | api.fda.gov |
| Orbray Co LTD | Tokyo, Japan | Specification developer | 1 | October 19, 2016 | 0 | 0 | 0 | api.fda.gov |
| Orbray Co., Ltd. | Yokote-shi Akita, Japan | Manufacturer | 1 | October 19, 2016 | 0 | 0 | 0 | api.fda.gov |
| Qinhuangdao Silide Ceramic Technology Co., Ltd. | Qinhuangdao Hebei, China | Contract manufacturer, Contract sterilizer, Exporter to the US, Foreign private label distributor, Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor, Specification developer | 1 | November 29, 2018 | 0 | 0 | 0 | api.fda.gov |
| Qinhuangdao Audental Metal Technology Co., Ltd. | Qinhuangdao City Hebei, China | Manufacturer | 1 | January 31, 2020 | 0 | 0 | 0 | api.fda.gov |
| Reliance Orthodontic Products, Inc. | Itasca, IL, United States | Repackager or relabeler, Specification developer | 1 | March 31, 1993 | 0 | 0 | 0 | api.fda.gov |
| Seattle Bioceramics, Inc. | Kent, WA, United States | Manufacturer | 1 | May 13, 2020 | 0 | 0 | 0 | api.fda.gov |
| SMD Dental Laboratory | Heungdeok-gu Cheongju-si Chungbuk, South Korea | Manufacturer | 1 | October 31, 2018 | 0 | 0 | 0 | api.fda.gov |
| Solventum Us LLC | Eagan, MN, United States | Complaint file establishment, Specification developer | 1 | November 14, 1985 | 0 | 0 | 0 | api.fda.gov |
| Solventum US LLC | San Antonio, TX, United States | Complaint file establishment, Specification developer | 1 | November 14, 1985 | 0 | 0 | 0 | api.fda.gov |
| Solventum US LLC | Irvine, CA, United States | Manufacturer | 1 | November 14, 1985 | 0 | 0 | 0 | api.fda.gov |
| Topzir Biotech Co., Ltd | Guangzhou Guangdong, China | Manufacturer | 1 | March 31, 2023 | 0 | 0 | 0 | api.fda.gov |
| U&c International Co., Ltd. | Ansan-si Gyeonggi, South Korea | Manufacturer | 1 | October 11, 2019 | 0 | 0 | 0 | api.fda.gov |
| Ultradent Products Inc. | South Jordan, UT, United States | Manufacturer | 1 | May 10, 1995 | 0 | 0 | 0 | api.fda.gov |
| Vericom Co., Ltd. | Chuncheon-Si Gangwon, South Korea | Manufacturer | 1 | July 1, 2021 | 0 | 0 | 0 | api.fda.gov |
| Wohlwend AG | Schellenberg, Liechtenstein | Manufacturer | 1 | April 2, 1999 | 0 | 0 | 0 | api.fda.gov |
| Yeti Dentalprodukte GMBH | Engen Baden-Wurttemberg, Germany | Manufacturer | 1 | November 15, 2018 | 0 | 0 | 0 | api.fda.gov |
| Zhejiang Zahndent Biotechnology Co.,ltd | Taizhou Zhejiang, China | Manufacturer | 1 | June 7, 2024 | 0 | 0 | 0 | api.fda.gov |
| Zirdent New Material Co.,ltd | Changsha Hunan, China | Manufacturer | 1 | November 12, 2021 | 0 | 0 | 0 | api.fda.gov |
| Amskorea Co.,ltd | Goyang-si Gyeonggi, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BMF Tech (zhuhai) Inc. | Zhuhai Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chemichl AG | Vaduz, Liechtenstein | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Degudent GMBH | Rosbach V.D.H. Hesse, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DS Rep B.V. | Las Piedras, PR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentsply IH AB | MOLNDAL Vastra Gotaland, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Digital Age Dental Laboratories, Ltd. | Vinh Tan Ward Ho Chi Minh, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Forbes Dental Prosthetics Inc. | Palanan Makati Central Luzon, Philippines | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Thales Medtech Co., Ltd. | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Idoc Dental Lab | Orange, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ivoclar Vivadent, Inc. | Lipa City Batangas, Philippines | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ivoclar Vivadent Manufacturing GmbH | NATURNO (BZ) Bolzano, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ivoclar Vivadent Manufacturing, Inc | Somerset, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangxi Rekonova Dental Materials Co., Ltd. | Jiujiang Jiangxi, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rizhao Huge Biomaterials Company, Ltd. | Rizhao Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straumann Manufacturing, Inc. | Mansfield, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.