Bar, Preformed (EHO): 17 FDA-registered makers in 10 countries

Name: FDA-registered makers of Bar, Preformed
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

17 establishments in 10 countries are registered with the FDA to make Bar, Preformed (product code EHO, Class 1, 21 CFR 872.3165). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on August 5, 1994, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: EHO
Device class: 1
Regulation: 872.3165
Medical specialty: Dental

Makers by country

Country	Makers
Germany	5
China	2
Switzerland	2
United States	2
Brazil	1
Ireland	1
Hong Kong	1
Italy	1
Colombia	1
Canada	1

Makers of Bar, Preformed

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	Source
Dental Morelli Ltda.	SOROCABA Sao Paulo, Brazil	Manufacturer	api.fda.gov
Dentaurum GmbH & Co. KG	ISPRINGEN Baden-Wurttemberg, Germany	Manufacturer	api.fda.gov
Foshan Nanhai Hongchen Medical Equipments Co.,ltd	Foshan Guangdong, China	Manufacturer	api.fda.gov
HADER Solutions & Distribution Ltd	Swords CO Dublin Dublin(County), Ireland	Manufacturer	api.fda.gov
Hebumedical GMBH	TUTTLINGEN Baden-Wurttemberg, Germany	Manufacturer	api.fda.gov
Helmut Zepf Medizintechnik GMBH	SEITINGEN Baden-Wurttemberg, Germany	Manufacturer	api.fda.gov
Hongkong DS Dental Technology Co. Limited	Tung Chung Lantau, Hong Kong	Manufacturer	api.fda.gov
Institut Straumann AG	BASEL Basel-Stadt, Switzerland	Specification developer	api.fda.gov
Instrumed GmbH dba Avalign German Specialty Instruments	TUTTLINGEN Baden-Wurttemberg, Germany	Manufacturer	api.fda.gov
Instrumed International Inc dba Avalign German Specialty Instruments	Schaumburg, IL, United States	Contract manufacturer, Repackager or relabeler	api.fda.gov
Nobil-Metal S P A	Villafranca Dasti, Italy	Manufacturer	api.fda.gov
Nuvia Mso	Salt Lake City, UT, United States	Specification developer	api.fda.gov
Nuvia Smiles SAS	galapa Atlantico, Colombia	Manufacturer	api.fda.gov
Panthera Dental Inc	Quebec City, Canada	Complaint file establishment, Manufacturer	api.fda.gov
Stryker Leibinger GMBH & Co. KG	FREIBURG Baden-Wurttemberg, Germany	Complaint file establishment, Specification developer	api.fda.gov
Straumann Villeret SA	VILLERET Bern, Switzerland	Manufacturer	api.fda.gov
Zhuhai DS Dental Technology Co., Ltd	Zhuhai Guangdong, China	Manufacturer	api.fda.gov

Updated August 5, 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.