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Data / Medical devices / Pusher, Band, Orthodontic

Pusher, Band, Orthodontic (ECS): 80 FDA-registered makers in 9 countries

80 establishments in 9 countries are registered with the FDA to make Pusher, Band, Orthodontic (product code ECS, Class 1, 21 CFR 872.4565). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on February 4, 1994, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
ECS
Device class
1
Regulation
872.4565
Medical specialty
Dental

Makers by country

CountryMakers
Pakistan22
United States19
Germany17
China12
Brazil3
South Korea3
Italy2
United Kingdom1
India1

Makers of Pusher, Band, Orthodontic

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
A. Schweickhardt GMBH & Co. KGSeitingen-Oberflacht Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
Accompany SurgicalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Acheron Instruments (pvt.) Ltd.LAHORE Punjab, PakistanManufacturer0000api.fda.gov
Ameda Instruments CompanyKarachi Sindh, PakistanExporter to the US, Manufacturer0000api.fda.gov
American OrthodonticsSheboygan, WI, United StatesContract manufacturer0000api.fda.gov
B. Ali ImpexSIALKOT, Punjab, PakistanManufacturer0000api.fda.gov
Central Surgical Co. Pvt. Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Comfort Surgical InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Confident InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Cislak Manufacturing, Inc.Niles, IL, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Daddy D ProSialkot Punjab, PakistanManufacturer0000api.fda.gov
Denta Craft InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Dental Morelli Ltda.SOROCABA Sao Paulo, BrazilManufacturer0000api.fda.gov
Devemed GMBHNEUHAUSEN OB ECK Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Dimeda Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Dentaurum GmbH & Co. KGISPRINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Dentsply Sirona Orthodontics Inc.Sarasota, FL, United StatesManufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Faulhaber Pinzetten KGFRITTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
GARNET DENTECH CorpDaegu, South KoreaManufacturer0000api.fda.gov
GC Orthodontics America Inc.Alsip, IL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Glenroe, LLCMilwaukee, WI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
GNI Co., LTDHwaseong-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Helmut Zepf Medizintechnik GMBHSEITINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Hu-Friedy MFG Co., LLCDes Plaines, IL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Hu-Friedy MFG. Co. LLCNorthbrook, IL, United StatesManufacturer0000api.fda.gov
Huanghua DK Dental Co., LtdHuangHua Hebei, ChinaManufacturer0000api.fda.gov
Hubei Guarddent Medical Technology Co.,ltdWuhan Hubei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Idm Tooling LLCCarrollton, TX, United StatesSpecification developer0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer0000api.fda.gov
J & J Instruments, LLCNorthbrook, IL, United StatesSpecification developer0000api.fda.gov
Jiangsu Province Yangzhou Shuguang Toothbrush ManufactoryYANG ZHOU Jiangsu, ChinaManufacturer0000api.fda.gov
Karl Hammacher GMBHSOLINGEN North Rhine-Westphalia, GermanyManufacturer0000api.fda.gov
KLS Martin Se & Co. KGFridingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
KLS Martin SE & Co. KGMuhlheim/Donau Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
KLS-Martin L.P.Jacksonville, FL, United StatesSpecification developer0000api.fda.gov
Leone SPASesto Fiorentino Firenze, ItalyManufacturer0000api.fda.gov
Lohar Medical CompanySialkot Punjab, PakistanManufacturer0000api.fda.gov
Med2b Ltd.Kitzingen Bavaria, GermanyManufacturer0000api.fda.gov
Medcave Private LimitedSialkot Punjab, PakistanManufacturer0000api.fda.gov
Medicon, E.G.TUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Meed Skills SurgicalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Melpex Beauty InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Ningbo Denrotary Medical Apparatus Co., Ltd.Ningbo City Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Nordent MFG., Inc.Elk Grove Village, IL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Nova InstrumentsBerkshire Wokingham, United KingdomContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Orthguide Medical Technology (jiangsu) Co., LtdWuxi City Jiangsu, ChinaManufacturer, Repackager or relabeler0000api.fda.gov
Ortho Organizers, Inc.Savannah, GA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Orthodontic Manufacturer Sia SRLROCCA D EVANDRO Caserta, ItalyManufacturer0000api.fda.gov
Orthometric Ind. E Com. De Prod. Med. Odont.Marilia Sao Paulo, BrazilManufacturer0000api.fda.gov
Osung MND Co., Ltd.Gimpo-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Otto Leibinger GMBHMUEHLHEIM Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Ormco CorporationPomona, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Ormco CorporationBrea, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Panorama International.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Pesitro Healthcare Products Co., Ltd.Yangzhou Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Power Dental USA, Inc.McHenry, IL, United StatesManufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Precision Beauty & Dental Instruments LLCHouston, TX, United StatesSpecification developer0000api.fda.gov
Qsa Surgical (pvt) Ltd.SIALKOT Punjab, PakistanContract manufacturer0000api.fda.gov
Richbolt EnterprisesSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Sawbros Industries Pvt LtdNOIDA Uttar Pradesh, IndiaManufacturer0000api.fda.gov
Schobell Industrial LtdaRio Claro Sao Paulo, BrazilManufacturer0000api.fda.gov
Shandong Hengfeng Kerui Medical Equipment Co., LtdQingdao City Shandong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Shanghai Kangqiao Dental Instruments FactoryShanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shanghai Medical Instruments (group) Ltd. Corp.Shanghai, ChinaManufacturer0000api.fda.gov
Silver Plus Corp.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Sobytek Instruments Co.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
SurjexSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Shenzhen Sunmc Dental Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Solventum Orthodontics CorporationMonrovia, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Stengelin Medical GmbHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Taurus Engineering And Manufacturing, Inc.Saint Paul, MN, United StatesContract manufacturer0000api.fda.gov
Technimen SkillersSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Tekno Medical Optik-Chirurgie GMBHTUTTLINGEN-Nendingen Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
Teufel & Gerlach GmbHTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Ustomed Instrumente GMBH & Co. KGTuttlingen Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Zain's Medical ImageSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Zepf Medical Instruments GMBHSEITINGEN-OBERFLACHT Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Zhejiang Protect Medical Equipment Co. Ltd.Anji Zhejiang, ChinaManufacturer0000api.fda.gov
Zhengzhou Huaer Electro-Optics Technology Co., Ltd.Zhengzhou Henan, ChinaManufacturer0000api.fda.gov

Updated February 4, 1994. 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.