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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

CountryMakers
China31
United States30
South Korea16
Germany12
Japan8
Liechtenstein4
Austria2
Switzerland2
Italy2
Philippines2
Canada1
Belgium1
Taiwan1
United Kingdom1
Hungary1
Sweden1
Vietnam1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Vita Zahnfabrik H. Rauter GMBH & Co. KG.BAD SACKINGEN Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler25February 21, 2025000api.fda.gov
Kuraray Noritake Dental Inc. Miyoshi PlantMIYOSHI Aichi, JapanManufacturer18May 29, 2025000api.fda.gov
Prismatik Dentalcraft, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler18July 30, 2026010api.fda.gov
Degudent GMBHHANAU Hesse, GermanyExporter to the US, Manufacturer, Specification developer14October 24, 2024000api.fda.gov
Ivoclar Vivadent AGSchaan, LiechtensteinManufacturer, Specification developer14March 10, 2026010api.fda.gov
Shofu Inc.FUKUINE, HIGASHIYAMA-KU Kyoto, JapanManufacturer14March 18, 2022000api.fda.gov
Klema Dentalprodukte GMBHMeiningen Vorarlberg, AustriaComplaint file establishment, Manufacturer11March 25, 2016000api.fda.gov
GENOSS Co., Ltd.Suwon-si Gyeonggi, South KoreaManufacturer10June 21, 2024000api.fda.gov
Institut Straumann AGBASEL Basel-Stadt, SwitzerlandComplaint file establishment, Exporter to the US, Specification developer8November 14, 2017000api.fda.gov
Amann Girrbach AGMaeder Vorarlberg, AustriaExporter to the US, Manufacturer7June 29, 2026000api.fda.gov
Dental Direkt GmbHSpenge North Rhine-Westphalia, GermanyContract manufacturer, Manufacturer, Repackager or relabeler7September 6, 2024000api.fda.gov
GC America Inc.Alsip, IL, United StatesComplaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler7February 3, 2017000api.fda.gov
Liaoning Upcera Co.,LtdBenxi Liaoning, ChinaManufacturer7January 9, 2026000api.fda.gov
Aidite (qinhuangdao) Technology Co., LtdQinhuangdao City Hebei, ChinaManufacturer6May 20, 2025000api.fda.gov
Dentsply LLCYork, PA, United StatesSpecification developer6August 12, 2016000api.fda.gov
Jensen Industries, Inc.North Haven, CT, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer6March 20, 2019000api.fda.gov
Shenzhen Xiangtong Co., Ltd.Dongguan Guangdong, ChinaManufacturer6December 8, 2025000api.fda.gov
Zirkonzahn SRLGais Bolzano, ItalyContract manufacturer, Manufacturer6December 14, 2022000api.fda.gov
etkon GMBHMarkkleeberg Saxony, GermanyManufacturer6November 14, 2017000api.fda.gov
Talladium, Inc.Santa Clarita, CA, United StatesManufacturer5September 15, 2016010api.fda.gov
The Argen CorporationSan Diego, CA, United StatesManufacturer, Manufacturer for export, Repackager or relabeler5October 24, 2024000api.fda.gov
The Argen CorporationSan Diego, CA, United StatesComplaint file establishment, Manufacturer, Manufacturer for export5October 24, 2024000api.fda.gov
Vatech mcis Co., Ltd.Suwon-si Gyeonggi, South KoreaManufacturer5June 20, 2023000api.fda.gov
Chengdu Besmile Medical Technology Co., Ltd.Chengdu Sichuan, ChinaExporter to the US, Manufacturer4March 19, 2024000api.fda.gov
DENTAL LABORATORY MILLING SUPPLIES LLC (DLMS) / Digital DentalScottsdale, AZ, United StatesSpecification developer4May 6, 2015000api.fda.gov
Imagine Milling Technologies, LLCChantilly, VA, United StatesContract manufacturer, Remanufacturer, Repackager or relabeler, Specification developer4February 27, 2023000api.fda.gov
Sagemax Bioceramics, Inc.Federal Way, WA, United StatesSpecification developer4December 16, 2015010api.fda.gov
ARUM DENTISTRY Co., Ltd.Yuseong-gu Daejeon, South KoreaManufacturer3July 10, 2025000api.fda.gov
Dentalmax Co., LtdCheonan-si Chungnam, South KoreaManufacturer3September 30, 2024000api.fda.gov
DMAX Co., Ltd.Daegu, South KoreaContract manufacturer, Manufacturer3June 12, 2025000api.fda.gov
GC Dental Products Corp.KASUGAI-SHI Aichi, JapanManufacturer3August 9, 2007000api.fda.gov
Hass Corp.Gangneung-si Gangwon, South KoreaManufacturer3June 11, 2026000api.fda.gov
Hass Corp.Gangneung-si Gangwon, South KoreaManufacturer3June 11, 2026000api.fda.gov
Hunan Vsmile Biotechnology Co.,ltdChangsha Hunan, ChinaExporter to the US, Manufacturer, Repackager or relabeler3November 13, 2024000api.fda.gov
Pritidenta GMBHLeinfelden-Echterdingen Baden-Wurttemberg, GermanyExporter to the US, Foreign private label distributor, Manufacturer3February 3, 2017000api.fda.gov
Proto3000 Inc.Vaughan Ontario, CanadaManufacturer3April 16, 2020000api.fda.gov
Shenzhen Yurucheng Dental Materials Co., Ltd.Shenzhen Guangdong, ChinaManufacturer3December 21, 2023000api.fda.gov
Sirona Dental Systems GMBHBENSHEIM Hesse, GermanyExporter to the US, Specification developer3August 1, 2018000api.fda.gov
Solventum Germany GmbHSEEFELD Bavaria, GermanyManufacturer3September 1, 2016000api.fda.gov
United Dental Resources CorporationUniversity Park, IL, United StatesManufacturer3February 23, 2021000api.fda.gov
Yilink (Tianjin) Biotechnology Co., Ltd.Tianjin, ChinaManufacturer3October 10, 2024000api.fda.gov
Bloomden Bioceramics (hunan) Co.,ltd.Changsha Hunan, ChinaManufacturer2March 30, 2026000api.fda.gov
Deprag High Tech Materials ( Zhengzhou ) Co.,ltd.ZHANGZHOU Henan, ChinaManufacturer2July 3, 2023000api.fda.gov
Dentaurum GmbH & Co. KGISPRINGEN Baden-Wurttemberg, GermanyManufacturer2June 5, 2001000api.fda.gov
Estetic Ceram AGTriesen, LiechtensteinContract manufacturer, Manufacturer2June 5, 2025000api.fda.gov
GC Corp.ITABASHI-KU Tokyo, JapanComplaint file establishment, Manufacturer2September 13, 2016000api.fda.gov
GC Corporation-Fuji Oyama FactorySUNTO-GUN, Shizuoka-Ken, JapanComplaint file establishment, Manufacturer2September 13, 2016000api.fda.gov
GC Europe N.V.LEUVEN Vlaams Brabant, BelgiumManufacturer, Repackager or relabeler2November 26, 2008000api.fda.gov
Ids KoreaSeoul, South KoreaManufacturer2October 11, 2019000api.fda.gov
Osstem Implant Co., Ltd.Gangseo-gu Seoul, South KoreaSpecification developer2November 20, 2024000api.fda.gov
Osstem Implant Co., Ltd.SIHEUNG Gyeonggi, South KoreaManufacturer2November 20, 2024000api.fda.gov
Shenzhen Up3d Tech Co., Ltd.Shenzhen Guangdong, ChinaManufacturer, Repackager or relabeler2May 25, 2023000api.fda.gov
Shandong Huge Dental Material CorporationRizhao Shandong, ChinaManufacturer2April 9, 2026000api.fda.gov
Whitepeaks Dental Solutions GMBHHamminkeln North Rhine-Westphalia, GermanyManufacturer2February 21, 2013000api.fda.gov
Amsusa LLCAtlanta, GA, United StatesManufacturer, Specification developer1May 4, 2017000api.fda.gov
Anhui Miisen Intelligence Technology Co., Ltd.Wuhu Anhui, ChinaExporter to the US, Manufacturer1May 31, 2024000api.fda.gov
B And D Dental CorporationWest Valley City, UT, United StatesManufacturer1August 11, 2011000api.fda.gov
Baot Biological Technology Co., Ltd.Zhongshan Guangdong, ChinaExporter to the US, Manufacturer1May 22, 2019000api.fda.gov
Bisco, Inc.Schaumburg, IL, United StatesContract manufacturer, Manufacturer1March 31, 1993000api.fda.gov
BMF Precision, Inc.Maynard, MA, United StatesComplaint file establishment, Specification developer1April 12, 2024000api.fda.gov
Cendres+metaux SABiel/Bienne Bern, SwitzerlandSpecification developer1January 15, 2020000api.fda.gov
Ceragroup IndustriesFort Lauderdale, FL, United StatesContract manufacturer, Manufacturer1August 26, 2000000api.fda.gov
Changsha Honchon Technology Co., LtdChangsha Hunan, ChinaManufacturer1July 8, 2022000api.fda.gov
COHO Advanced Materials Tech. Co., Ltd.Luzhu District Taoyuan, TaiwanManufacturer1June 17, 2015000api.fda.gov
Creamed GMBH & Co. Produktions- Und Handels KGMarburg Hesse, GermanyManufacturer1September 24, 2013000api.fda.gov
Davis Schottlander & Davis, Ltd.LETCHWORTH, HERTS. Hertfordshire, United KingdomExporter to the US, Manufacturer, Repackager or relabeler, Specification developer1August 25, 2003000api.fda.gov
De Corematrix Co.ltd.Jiujiang Jiangxi, ChinaManufacturer1May 29, 2020000api.fda.gov
Den-Mat Holdings, LLCLompoc, CA, United StatesComplaint file establishment, Manufacturer1August 25, 2025000api.fda.gov
DENKEN-HIGHDENTAL Co., Ltd.Kyoto, JapanComplaint file establishment, Manufacturer1July 14, 2022000api.fda.gov
DENTSPLY IH Inc.Waltham, MA, United StatesManufacturer1January 29, 2016000api.fda.gov
Doctus GlobalGoyang-si, Gyeonggi-do, South KoreaManufacturer1June 30, 2023000api.fda.gov
Fuzhou Rick Brown Biomaterials Co. Ltd.Fuzhou Fujian, ChinaManufacturer1July 3, 2023000api.fda.gov
Hangzhou Ivista Medical Devices Co., LtdHangzhou Zhejiang, ChinaManufacturer1January 12, 2024000api.fda.gov
Hiossen, Inc.Morrisville, PA, United StatesManufacturer1October 31, 2018000api.fda.gov
Hunan Ceramaster Material Technology Co., LtdChangsha Hunan, ChinaManufacturer1May 20, 2024000api.fda.gov
Hunan Hualian Special Ceramics Co., LtdZhuzhou Hunan, ChinaExporter to the US, Manufacturer1July 9, 2024000api.fda.gov
Hunan Qinghaopuzhong Technology Co., Ltd.Zhuzhou Hunan, ChinaManufacturer1August 30, 2024000api.fda.gov
Kerox KFT.Soskut Pest, HungaryManufacturer1June 6, 2012000api.fda.gov
Keystone Industries - GibbstownGibbstown, NJ, United StatesContract manufacturer, Manufacturer1March 27, 2003000api.fda.gov
Liaoning Rachcera Material Technology Co.,ltd.Shenyang Liaoning, ChinaManufacturer1December 5, 2024000api.fda.gov
Mediclus Co., LtdCheongju-si Chungbuk, South KoreaManufacturer1August 21, 2026000api.fda.gov
Monde Dental LabShenzhen Guangdong, ChinaManufacturer1July 6, 2009000api.fda.gov
Orbray Co LTDTokyo, JapanSpecification developer1October 19, 2016000api.fda.gov
Orbray Co., Ltd.Yokote-shi Akita, JapanManufacturer1October 19, 2016000api.fda.gov
Qinhuangdao Silide Ceramic Technology Co., Ltd.Qinhuangdao Hebei, ChinaContract manufacturer, Contract sterilizer, Exporter to the US, Foreign private label distributor, Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor, Specification developer1November 29, 2018000api.fda.gov
Qinhuangdao Audental Metal Technology Co., Ltd.Qinhuangdao City Hebei, ChinaManufacturer1January 31, 2020000api.fda.gov
Reliance Orthodontic Products, Inc.Itasca, IL, United StatesRepackager or relabeler, Specification developer1March 31, 1993000api.fda.gov
Seattle Bioceramics, Inc.Kent, WA, United StatesManufacturer1May 13, 2020000api.fda.gov
SMD Dental LaboratoryHeungdeok-gu Cheongju-si Chungbuk, South KoreaManufacturer1October 31, 2018000api.fda.gov
Solventum Us LLCEagan, MN, United StatesComplaint file establishment, Specification developer1November 14, 1985000api.fda.gov
Solventum US LLCSan Antonio, TX, United StatesComplaint file establishment, Specification developer1November 14, 1985000api.fda.gov
Solventum US LLCIrvine, CA, United StatesManufacturer1November 14, 1985000api.fda.gov
Topzir Biotech Co., LtdGuangzhou Guangdong, ChinaManufacturer1March 31, 2023000api.fda.gov
U&c International Co., Ltd.Ansan-si Gyeonggi, South KoreaManufacturer1October 11, 2019000api.fda.gov
Ultradent Products Inc.South Jordan, UT, United StatesManufacturer1May 10, 1995000api.fda.gov
Vericom Co., Ltd.Chuncheon-Si Gangwon, South KoreaManufacturer1July 1, 2021000api.fda.gov
Wohlwend AGSchellenberg, LiechtensteinManufacturer1April 2, 1999000api.fda.gov
Yeti Dentalprodukte GMBHEngen Baden-Wurttemberg, GermanyManufacturer1November 15, 2018000api.fda.gov
Zhejiang Zahndent Biotechnology Co.,ltdTaizhou Zhejiang, ChinaManufacturer1June 7, 2024000api.fda.gov
Zirdent New Material Co.,ltdChangsha Hunan, ChinaManufacturer1November 12, 2021000api.fda.gov
Amskorea Co.,ltdGoyang-si Gyeonggi, South KoreaContract manufacturer0000api.fda.gov
BMF Tech (zhuhai) Inc.Zhuhai Guangdong, ChinaContract manufacturer0000api.fda.gov
Chemichl AGVaduz, LiechtensteinContract manufacturer0000api.fda.gov
Degudent GMBHRosbach V.D.H. Hesse, GermanyContract manufacturer0000api.fda.gov
DS Rep B.V.Las Piedras, PR, United StatesContract manufacturer0000api.fda.gov
Dentsply IH ABMOLNDAL Vastra Gotaland, SwedenContract manufacturer0000api.fda.gov
Digital Age Dental Laboratories, Ltd.Vinh Tan Ward Ho Chi Minh, VietnamManufacturer0000api.fda.gov
Forbes Dental Prosthetics Inc.Palanan Makati Central Luzon, PhilippinesContract manufacturer0000api.fda.gov
Hangzhou Thales Medtech Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Idoc Dental LabOrange, CA, United StatesContract manufacturer0000api.fda.gov
Ivoclar Vivadent, Inc.Lipa City Batangas, PhilippinesContract manufacturer0000api.fda.gov
Ivoclar Vivadent Manufacturing GmbHNATURNO (BZ) Bolzano, ItalyContract manufacturer0000api.fda.gov
Ivoclar Vivadent Manufacturing, IncSomerset, NJ, United StatesContract manufacturer0000api.fda.gov
Jiangxi Rekonova Dental Materials Co., Ltd.Jiujiang Jiangxi, ChinaContract manufacturer0000api.fda.gov
Rizhao Huge Biomaterials Company, Ltd.Rizhao Shandong, ChinaManufacturer0000api.fda.gov
Straumann Manufacturing, Inc.Mansfield, TX, United StatesContract manufacturer0000api.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.