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Data / Medical devices / Wax, Dental, Intraoral

Wax, Dental, Intraoral (EGD): 136 FDA-registered makers in 24 countries

136 establishments in 24 countries are registered with the FDA to make Wax, Dental, Intraoral (product code EGD, Class 1, 21 CFR 872.6890). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 25 510(k) clearances under this code, the latest on February 11, 2002, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
EGD
Device class
1
Regulation
872.6890
Medical specialty
Dental

Makers by country

CountryMakers
China48
United States37
Germany9
South Korea5
Pakistan4
Mexico4
Japan4
India3
United Kingdom2
Switzerland2
Taiwan2
Brazil2
Italy2
Colombia2
United Arab Emirates1
Turkey1
Dominican Republic1
Canada1
Netherlands1
Hong Kong1
Vietnam1
Australia1
Belgium1
Spain1

Makers of Wax, Dental, Intraoral

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
Garreco, LLCHeber Springs, AR, United StatesManufacturer7August 21, 1991000api.fda.gov
Kulzer, LLCSouth Bend, IN, United StatesContract manufacturer, Manufacturer2November 17, 1992000api.fda.gov
Accompany SurgicalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Advanced Dental DesignsMoreno Valley, CA, United StatesManufacturer0000api.fda.gov
Aidite (qinhuangdao) Technology Co., LtdQinhuangdao City Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
American OrthodonticsSheboygan, WI, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Anqing Clean Dental Instrument Technology Co.,ltdAnqing City Anhui, ChinaExporter to the US, Manufacturer0000api.fda.gov
Arak Dental LabSharjah Dubayy, United Arab EmiratesManufacturer0000api.fda.gov
Asap LLCSanta Fe Spgs, CA, United StatesManufacturer0000api.fda.gov
Ashtel Studios, Inc.Ontario, CA, United StatesSpecification developer0000api.fda.gov
Associated Dental Products LtdSwindon Wiltshire, United KingdomManufacturer0000api.fda.gov
ATRIA Co.Seoul, South KoreaManufacturer0000api.fda.gov
Aadi Med Private LimitedDist. Palghar Maharashtra, IndiaManufacturer0000api.fda.gov
Bilkim Ltd Co.Izmir, TurkeyContract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Bisco, Inc.Schaumburg, IL, United StatesContract manufacturer0000api.fda.gov
Bredent GMBH & Co.kgSENDEN Bavaria, GermanyManufacturer0000api.fda.gov
Calibaja Manufacturing, S.A. De C.V.MEXICALI Baja California, MexicoContract manufacturer0000api.fda.gov
Candulor, AGGlattpark Zurich, SwitzerlandManufacturer0000api.fda.gov
Cangzhou Lankang Medical Instruments Developing Co., Ltd.Cangzhou Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Caribbean Custom Mold IncSanto Domingo, Dominican RepublicContract manufacturer0000api.fda.gov
Carmel IndustriesMontreal Quebec, CanadaManufacturer0000api.fda.gov
Cavex Holland B.V.HAARLEM Noord-Holland, NetherlandsManufacturer0000api.fda.gov
Changshu Shangchi Dental Materials Co., Ltd.Changshu Jiangsu, ChinaManufacturer0000api.fda.gov
Chewink Corp.New Taipei City, TaiwanManufacturer0000api.fda.gov
Coltene/Whaledent Inc.Cuyahoga Falls, OH, United StatesManufacturer0000api.fda.gov
Coral Healthcare Products Manufacturer Co., Ltd.YANGZHOU Jiangsu, ChinaManufacturer0000api.fda.gov
Debo Medical Technology (shijiazhuang) Co., Ltd.Shijiazhuang Hebei, ChinaContract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
DENKEN-HIGHDENTAL Co., Ltd.Kyoto, JapanComplaint file establishment, Manufacturer0000api.fda.gov
Denta Craft InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
DENTACO GmbH & Co. KGEssen North Rhine-Westphalia, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Dental Morelli Ltda.SOROCABA Sao Paulo, BrazilManufacturer0000api.fda.gov
Dentos, IncorporatedDaegu, South KoreaManufacturer0000api.fda.gov
Digital Dental Depotzhuhai Guangdong, ChinaContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Digital Dental Depot LimitedHong Kong, Hong KongContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
DIO CorporationHaeundae-gu Busan, South KoreaManufacturer0000api.fda.gov
DenTek Oral Care, Inc.Tarrytown, NY, United StatesSpecification developer0000api.fda.gov
Dentaurum GmbH & Co. KGISPRINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Digital Age Dental Laboratories, Ltd.Vinh Tan Ward Ho Chi Minh, VietnamExporter to the US, Manufacturer0000api.fda.gov
Dr. Jean Bausch GmbH & Co. KGCOLOGNE North Rhine-Westphalia, GermanyManufacturer0000api.fda.gov
Endo Tech InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Erskine DentalMACKSVILLE New South Wales, AustraliaExporter to the US, Specification developer0000api.fda.gov
Elemental NVGhent Oost-Vlaanderen, BelgiumExporter to the US, Specification developer0000api.fda.gov
Freeman Manufacturing & Supply Co.Avon, OH, United StatesContract manufacturer, Manufacturer0000api.fda.gov
GC Corp.ITABASHI-KU Tokyo, JapanManufacturer0000api.fda.gov
GC Orthodontics America Inc.Alsip, IL, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Gebdi Dental Products GMBHEngen Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Guangzhou Cheer-U Material Technology Co., LtdGuangzhou Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Gurunanda LLCBuena Park, CA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Great Lakes Dental Technologies, Ltd.Tonawanda, NY, United StatesSpecification developer0000api.fda.gov
Hager Worldwide, Inc.Hickory, NC, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Hangzhou Pengwu Medical Equipment Co.,ltdHangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Hangzhou Wise Medical Device Co.,ltdHangzhou Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Henan Baistra Medical Devices LimitedZhengzhou Henan, ChinaExporter to the US, Manufacturer0000api.fda.gov
Huanghua DK Dental Co., LtdHuangHua Hebei, ChinaManufacturer0000api.fda.gov
Huanghua Promisee Dental Co., LtdHuanghua Hebei, ChinaManufacturer0000api.fda.gov
Hubei Guarddent Medical Technology Co.,ltdWuhan Hubei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hunan Vsmile Biotechnology Co.,ltdChangsha Hunan, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Huliang (shanghai) Bio-Tech Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer0000api.fda.gov
Ivoclar Vivadent Manufacturing, IncSomerset, NJ, United StatesContract manufacturer0000api.fda.gov
J-Energy Daily Care Products Co.,ltdYangzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Jiangsu Bailu Brushes Co., LtdYANGZHOU Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Jiangsu Province Yangzhou Shuguang Toothbrush ManufactoryYANG ZHOU Jiangsu, ChinaManufacturer0000api.fda.gov
Jiscop Co., Ltd.Gunpo-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Kent Manufacturing CompanyGrand Rapids, MI, United StatesContract manufacturer0000api.fda.gov
Kerr CorporationPomona, CA, United StatesManufacturer0000api.fda.gov
Keystone IndustriesMyerstown, PA, United StatesSpecification developer0000api.fda.gov
Leone SPASesto Fiorentino Firenze, ItalyManufacturer, Specification developer0000api.fda.gov
Libral Traders Pvt. Ltd.New Delhi, IndiaManufacturer0000api.fda.gov
Manufacturera Dental ContinentalZAPOPAN Jalisco, MexicoComplaint file establishment, Manufacturer0000api.fda.gov
Maquira Industria De Produtos OdontologicosMaringa Parana, BrazilManufacturer0000api.fda.gov
Mediclus Co., LtdCheongju-si Chungbuk, South KoreaManufacturer0000api.fda.gov
Medtech Products, Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Memphis Dental MFG. Co., Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Merz Dental GMBHLUETJENBURG Schleswig-Holstein, GermanyManufacturer0000api.fda.gov
Natural EstheticsFuessen Bavaria, GermanyManufacturer0000api.fda.gov
New Phenix Home Products Manufactory Co., Ltd.YANGZHOU Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
New SteticGUARNE Antioquia, ColombiaManufacturer0000api.fda.gov
Nimi Chemical Industrial Co., Ltd.Kiryu Gunma, JapanManufacturer0000api.fda.gov
Ningbo Haishu Zonghai Artware Co., Ltd.Ningbo City Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
O&S Dental, Inc.Chicago, IL, United StatesManufacturer0000api.fda.gov
Ortho Organizers, Inc.Savannah, GA, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Orvance, LLCCaledonia, MI, United StatesSpecification developer0000api.fda.gov
Ormco CorporationBrea, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Pac-Dent Inc.Brea, CA, United StatesManufacturer0000api.fda.gov
Pesitro Healthcare Products Co., Ltd.Yangzhou Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Placecol S.Afunza Cundinamarca, ColombiaManufacturer0000api.fda.gov
Prevest Denpro LimitedJammu Jammu and Kashmir, IndiaManufacturer0000api.fda.gov
Prime Dental Manufacturing, Inc.Chicago, IL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Qingdao Jinpuguangyuan Science And Technology Co.,ltdQingdao Shandong, ChinaManufacturer0000api.fda.gov
Ranir LLCGrand Rapids, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Reko Dental, LLCGardena, CA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Reliance Orthodontic Products, Inc.Itasca, IL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Rosemarie Products Company, LLCMason, OH, United StatesSpecification developer0000api.fda.gov
Ranir Changshu Oral Care CO., LtdChangshu Jiangsu, ChinaManufacturer0000api.fda.gov
Sagemax Bioceramics, Inc.Federal Way, WA, United StatesSpecification developer0000api.fda.gov
Scanderra LLB AGBasel Basel-Stadt, SwitzerlandSpecification developer0000api.fda.gov
Shandong Hengfeng Kerui Medical Equipment Co., LtdQingdao City Shandong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Shanghai Lions Industrial Co.,ltd.Shanghai, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Shen Fu Arts LabShen Zhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Denco Medical Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Shenzhen Rogin Medical Co., Ltdshenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Shenzhen Yongchanghe Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Yuechuan Trade Co., Ltd.shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shumei Industrial (hebei) Co., Ltd.Cangzhou Hebei, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Signor Seven InternationalSialkot Punjab, PakistanManufacturer0000api.fda.gov
ST. George Technology, Inc.Wilmington, NC, United StatesSpecification developer0000api.fda.gov
Sunstar Americas, Inc.Schaumburg, IL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Shandong Huge Dental Material CorporationRizhao Shandong, ChinaManufacturer0000api.fda.gov
Shanghai Jolly Industrial Co., Ltd.Shanghai, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Sharp Detail Orthodontic Laboratory S DE EL DE CVTijuana Baja California, MexicoManufacturer0000api.fda.gov
Shenzhen Golden Wish Personal Care Co.,LtdShenzhen Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shenzhen Sunmc Dental Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shummi Enterprise Co., Ltd.Taipei, TaiwanContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Solventum Orthodontics CorporationMonrovia, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Sonrisa/Easy Denture/NSIWilmington, NC, United StatesSpecification developer0000api.fda.gov
Union Dental S.A.TIELMES Madrid(Province), SpainManufacturer0000api.fda.gov
Ultradent Products Inc.South Jordan, UT, United StatesManufacturer0000api.fda.gov
Vago International Manufacturing SA De CVMonterrey Nuevo Leon, MexicoContract manufacturer0000api.fda.gov
Vita Zahnfabrik H. Rauter GMBH & Co. KG.BAD SACKINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Weihai Jieshi Commodity Manufacture Co. Ltd.Weihai,Shandong, ChinaManufacturer0000api.fda.gov
Wright Health GroupDundee Dundee City, United KingdomSpecification developer0000api.fda.gov
Wuhu Guli Ortho Co.,ltdWuhu Anhui, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Wellmed Dental Medical Supply Co., LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Xiamen Antinsky Industry Co., LtdXiamen Fujian, ChinaExporter to the US, Manufacturer0000api.fda.gov
Yamahachi Dental MFG. Co.Gamagori City Aichi, JapanComplaint file establishment, Specification developer0000api.fda.gov
Yangzhou Chenxiao Brush Industrial Co., Ltd.YANGZHOU Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Yangzhou Royal Home Products Manufacture Co., Ltd.Yangzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Yeti Dentalprodukte GMBHEngen Baden-Wurttemberg, GermanyManufacturer, Specification developer0000api.fda.gov
Yamahachi Dental Material (Changshu) Co., Ltd.Changshu city Jiangsu, ChinaManufacturer0000api.fda.gov
Yangzhou Yichuan Plastic Technology Co., Ltd.Yangzhou City Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Zhejiang Jasmine Oralcare Products Co., Ltd.Jiaxing Zhejiang, ChinaContract manufacturer, Foreign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Zhejiang Mediunion Healthcare Group Co.,ltdNingbo Zhejiang, ChinaManufacturer0000api.fda.gov
Zhejiang Yamei Medical Equipment Technology Co., Ltd.Yang Jiao Lang Zin'an Town Zhejiang, ChinaManufacturer0000api.fda.gov
Zirkonzahn SRLGais Bolzano, ItalyManufacturer0000api.fda.gov
ZOGEAR Medical Co., Ltd.Yizheng Jiangsu, ChinaManufacturer0000api.fda.gov

Updated February 11, 2002. 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.