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Data / Medical devices / Holder, Film, X-Ray

Holder, Film, X-Ray (EGZ): 82 FDA-registered makers in 15 countries

82 establishments in 15 countries are registered with the FDA to make Holder, Film, X-Ray (product code EGZ, Class 1, 21 CFR 872.1905). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on September 6, 1991, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
EGZ
Device class
1
Regulation
872.1905
Medical specialty
Dental

Makers by country

CountryMakers
China33
United States20
Pakistan11
Canada3
Taiwan3
Germany3
Finland1
Sweden1
Netherlands1
India1
Brazil1
Dominican Republic1
Italy1
Czechia1
New Zealand1

Makers of Holder, Film, X-Ray

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
Accompany SurgicalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Acheron Instruments (pvt.) Ltd.LAHORE Punjab, PakistanManufacturer0000api.fda.gov
Acme EnterprisesSialkot Punjab, PakistanManufacturer0000api.fda.gov
Athlos OYEspoo Uusimaa, FinlandComplaint file establishment, Manufacturer0000api.fda.gov
B. Ali ImpexSIALKOT, Punjab, PakistanManufacturer0000api.fda.gov
Beyes Dental IncToronto Ontario, CanadaManufacturer0000api.fda.gov
BGSS Company Asia LimitedZhabei Shanghai, ChinaContract manufacturer, Repackager or relabeler0000api.fda.gov
BH Medical Products Co., LtdChangzhou City Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
BiometerPlus USA, Inc.Fremont, CA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Cangzhou Lankang Medical Instruments Developing Co., Ltd.Cangzhou Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Carwild Corp.New London, CT, United StatesContract manufacturer0000api.fda.gov
Cliktech, LLC.Scottsdale, AZ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Comfort Surgical InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Confident InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Coomex Sources Co. Ltd.Qingdao City Shandong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Daddy D ProSialkot Punjab, PakistanManufacturer0000api.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
Denta Craft InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Dentsply LLCYork, PA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Dhef Inc.New Taipei City, TaiwanManufacturer0000api.fda.gov
Directa ABUPPLANDS VAESBY Stockholm, SwedenManufacturer0000api.fda.gov
DMG Chemisch Pharmazeutische Fabrik GMBHHamburg, GermanyManufacturer0000api.fda.gov
Dongguan Yilong Medical Supplies Co.. Ltd.Dongguan Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Duphamed B.V.ALPHEN AAN DEN RIJN Zuid-Holland, NetherlandsManufacturer0000api.fda.gov
Durr Dental SeBietigheim-Bissingen Baden-Wurttemberg, GermanyComplaint file establishment, Specification developer0000api.fda.gov
Dental Imaging Technologies CorporationQuakertown, PA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Dentsply Sirona Orthodontics Inc.Sarasota, FL, United StatesContract manufacturer0000api.fda.gov
Durr Optronik GmbH & Co. KGGechingen Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Fredricks/Plasteel Corp.Inkster, MI, United StatesManufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Guangdong Xinuo Personal Care Products Co., LtdYunfu City Guangdong, ChinaManufacturer0000api.fda.gov
Guangzhou Four E's Scientific Co., Ltd.GUANGZHOU Guangdong, ChinaSpecification developer0000api.fda.gov
Hager Worldwide, Inc.Hickory, NC, United StatesComplaint file establishment, Specification developer0000api.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
Hangzhou Fushan Medical Appliance Co., Ltd.Hangzhou City Zhejiang, ChinaContract manufacturer, Repackager or relabeler0000api.fda.gov
Heuer International (A division of GST Corporation Limited)NOIDA Uttar Pradesh, IndiaForeign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Inter-Med, Inc.Racine, WI, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesManufacturer0000api.fda.gov
Jinyuan Medical Equipment(tianjin)co.,ltdTianjin, ChinaManufacturer0000api.fda.gov
Lakong Medical Devices Co., Ltd.Dongguan Guangdong, ChinaManufacturer0000api.fda.gov
Maco Bag Corp.Newark, NY, United StatesContract manufacturer0000api.fda.gov
Maquira Industria De Produtos OdontologicosMaringa Parana, BrazilManufacturer0000api.fda.gov
Medsorb Dominicana, S.A.San Pedro De Macoris, Dominican RepublicContract manufacturer, Manufacturer0000api.fda.gov
Microcopy, Division Of Neo-Flo, Inc.Kennesaw, GA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Omnia SRLFIDENZA Parma, ItalySpecification developer0000api.fda.gov
Onvet Medical Canada IncTORONTO Ontario, CanadaManufacturer0000api.fda.gov
Panorama International.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Plasdent Shanghai Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Practicon, Inc.Greenville, NC, United StatesSpecification developer0000api.fda.gov
Premium Plus (dongguan) LimitedDongguan Guangdong, ChinaManufacturer, Repackager or relabeler0000api.fda.gov
Proedge Dental ProductsCentennial, CO, United StatesSpecification developer0000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesSpecification developer0000api.fda.gov
Shanghai Alwings Medical Instrument Co.,ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Shanghai Dochem Industries Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Shanghai Lions Industrial Co.,ltd.Shanghai, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Shengiho Enterprise Co., Ltd.Taichung City, TaiwanManufacturer0000api.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 Xpectvision Technology Co., Ltd.Shenzhen Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Steri-Shield IncorporatedFernandina Beach, FL, United StatesManufacturer, Specification developer0000api.fda.gov
SurgicraftsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Shanghai Jolly Industrial Co., Ltd.Shanghai, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Shenzhen Senlede Technologies Co., LtdShenzhen Guangdong, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
SpofaDental a.s.Jicin, CzechiaContract manufacturer0000api.fda.gov
Tangshan Zhengtong Exhibition Co., Ltd.Tangshan Hebei, ChinaManufacturer0000api.fda.gov
Techno-Aide, Inc.Whites Creek, TN, United StatesManufacturer0000api.fda.gov
Temrex Corp.Freeport, NY, United StatesManufacturer0000api.fda.gov
Tianchang Jiarui Packaging Material Co., Ltd.Tianchang Anhui, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Tianjin Water Source Tech Co., Ltd.Tianjin, ChinaManufacturer0000api.fda.gov
Tidi Products, LLCNeenah, WI, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Top Operator ProductsCAMBRIDGE Waikato, New ZealandManufacturer0000api.fda.gov
Tornado PlasticsSt-Laurent Quebec, CanadaManufacturer0000api.fda.gov
Tribest Dental Products Co LtdYangzhong Jiangsu, ChinaManufacturer0000api.fda.gov
Ttbio CorporationTaichung, TaiwanManufacturer0000api.fda.gov
Trelleborg Sealing Solutions Suzhou Company LimitedSuzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
Weihai Xingtai Packaging Products Co., Ltd.WeiHai Shandong, ChinaManufacturer0000api.fda.gov
Wolf X-Ray CorpBattleboro, NC, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Wenzhou Wapro Technology CO LTDLonggang Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Zhejiang Yamei Medical Equipment Technology Co., Ltd.Yang Jiao Lang Zin'an Town Zhejiang, ChinaManufacturer0000api.fda.gov
ZOGEAR Medical Co., Ltd.Yizheng Jiangsu, ChinaManufacturer0000api.fda.gov

Updated September 6, 1991. 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.