Data / Medical devices / Dental Implant Surgical Tray

Dental Implant Surgical Tray (OFY): 17 FDA-registered makers in 11 countries

Name: FDA-registered makers of Dental Implant Surgical Tray
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

17 establishments in 11 countries are registered with the FDA to make Dental Implant Surgical Tray (product code OFY, Class 1, 21 CFR 872.3980). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 1 recall event (0 Class I). FDA data exported November 3, 2026.

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Product code: OFY
Device class: 1
Regulation: 872.3980
Medical specialty: Dental

Makers by country

Country	Makers
United States	5
Israel	2
China	2
Spain	1
Mexico	1
Poland	1
Pakistan	1
Germany	1
South Korea	1
Switzerland	1
France	1

Makers of Dental Implant Surgical Tray

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
Adin Dental Implant Systems Ltd.	Afula Northern, Israel	Manufacturer	api.fda.gov
B.T.I. Biotechnology Institute, S.L.	Miñano Alava, Spain	Manufacturer	api.fda.gov
Cangzhou Lankang Medical Instruments Developing Co., Ltd.	Cangzhou Hebei, China	Exporter to the US, Manufacturer	api.fda.gov
Cardinal Health 200, LLC	El Paso, TX, United States	Manufacturer	api.fda.gov
Convertors de Mexico S. de R.L. de C.V	CD.JUAREZ Chihuahua, Mexico	Manufacturer, Repackager or relabeler	api.fda.gov
Ditron Dental Ltd	Ashkelon Southern, Israel	Manufacturer	api.fda.gov
Dental Engineering Laboratories, LLC	Goleta, CA, United States	Specification developer	api.fda.gov
Fabryka Narzedzi Medycznych CHIRMED Marcin Dyner Spolka Komandytowa	RUDNIKI K/CZESTOCHOWY Slaskie, Poland	Manufacturer	api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, Pakistan	Manufacturer	api.fda.gov
Hager & Meisinger GMBH	NEUSS North Rhine-Westphalia, Germany	Manufacturer	api.fda.gov
Huanghua DK Dental Co., Ltd	HuangHua Hebei, China	Manufacturer	api.fda.gov
Imagine Milling Technologies, LLC	Chantilly, VA, United States	Manufacturer for export	api.fda.gov
Keystone Dental Inc.	Irvine, CA, United States	Manufacturer	api.fda.gov
Ossvis Co., Ltd.	Anyang-si Gyeonggi, South Korea	Manufacturer	api.fda.gov
Sic Invent AG	Basel Town Basel-Landschaft, Switzerland	Manufacturer	api.fda.gov
Symmetry Medical Polyvac SAS	WAMBRECHIES Nord, France	Contract manufacturer	api.fda.gov
Symmetry Medical, Inc. - Manchester	Manchester, NH, United States	Contract manufacturer	api.fda.gov

Updated November 3, 2026. 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.