Data / Medical devices / Clasp, Preformed

Clasp, Preformed (EHP): 16 FDA-registered makers in 9 countries

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

16 establishments in 9 countries are registered with the FDA to make Clasp, Preformed (product code EHP, Class 1, 21 CFR 872.3285). 1 of them has 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 August 29, 2002, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: EHP
Device class: 1
Regulation: 872.3285
Medical specialty: Dental

Makers by country

Country	Makers
United States	4
Germany	3
China	3
Trinidad and Tobago	1
Pakistan	1
Taiwan	1
Italy	1
Mexico	1
Japan	1

Makers of Clasp, 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	510(k) clearances	Latest clearance	Source
The Myerson Company Limited	Laventille San JuanLaventille, Trinidad and Tobago	Manufacturer	1	August 29, 2002	api.fda.gov
Dentaurum GmbH & Co. KG	ISPRINGEN Baden-Wurttemberg, Germany	Manufacturer	0		api.fda.gov
Forestadent Bernhard Forster GMBH	PFORZHEIM Baden-Wurttemberg, Germany	Manufacturer	0		api.fda.gov
Fseven Dental Technology Zhuhai Co.,ltd	ZHUHAI Guangdong, China	Exporter to the US, Manufacturer	0		api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, Pakistan	Manufacturer	0		api.fda.gov
GC Orthodontics America Inc.	Alsip, IL, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	0		api.fda.gov
Jin Hsiang Ent Co. Ltd	Changhua, Taiwan	Contract manufacturer, Manufacturer	0		api.fda.gov
Leone SPA	Sesto Fiorentino Firenze, Italy	Manufacturer, Specification developer	0		api.fda.gov
Ortho Organizers, Inc.	Savannah, GA, United States	Manufacturer, Repackager or relabeler	0		api.fda.gov
RICOmed Manufacturing	Richardson, TX, United States	Contract manufacturer, Repackager or relabeler	0		api.fda.gov
Rmo	Franklin, IN, United States	Manufacturer, Repackager or relabeler	0		api.fda.gov
Scheu-Dental GMBH	ISERLOHN North Rhine-Westphalia, Germany	Manufacturer	0		api.fda.gov
Shanghai Kangqiao Dental Instruments Factory	Shanghai, China	Exporter to the US, Manufacturer	0		api.fda.gov
Sharp Detail Orthodontic Laboratory S DE EL DE CV	Tijuana Baja California, Mexico	Manufacturer	0		api.fda.gov
Tomy, Inc.	Iwaki City Fukushima, Japan	Manufacturer	0		api.fda.gov
Yamahachi Dental Material (Changshu) Co., Ltd.	Changshu city Jiangsu, China	Manufacturer	0		api.fda.gov

Updated August 29, 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.