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Data / Medical devices / Tray, Fluoride, Disposable

Tray, Fluoride, Disposable (KMT): 37 FDA-registered makers in 10 countries

37 establishments in 10 countries are registered with the FDA to make Tray, Fluoride, Disposable (product code KMT, Class 1, 21 CFR 872.6870). 2 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 January 23, 2004, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
KMT
Device class
1
Regulation
872.6870
Medical specialty
Dental

Makers by country

CountryMakers
China17
United States11
Germany2
Canada1
Hong Kong1
Pakistan1
South Korea1
France1
Turkey1
India1

Makers of Tray, Fluoride, Disposable

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
Ohlendorf CompanyAffton, MO, United StatesManufacturer1January 23, 2004000api.fda.gov
Perio Protect LLCSaint Louis, MO, United StatesManufacturer1January 23, 2004000api.fda.gov
AMD Medicom Inc.Pointe-Claire, Montreal Quebec, CanadaComplaint file establishment, Exporter to the US, Specification developer0000api.fda.gov
Anqing Clean Dental Instrument Technology Co.,ltdAnqing City Anhui, ChinaExporter to the US, Manufacturer0000api.fda.gov
BGSS Company Asia LimitedZhabei Shanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Buffalo Dental Mfg Co IncHancock, NY, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
China Zhong Yan Chang Xing International Co. LtdZibo City Shandong, ChinaContract manufacturer0000api.fda.gov
Creator Digital Dental Technology Co.ltdZhuhai Guangdong, ChinaManufacturer0000api.fda.gov
Crosstex InternationalRush, NY, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Den-Mat Holdings, LLCLompoc, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Exceldent Dental Technology Development Co., Ltd.Zhuhai Guangdong, ChinaManufacturer0000api.fda.gov
F-Six Dental Technology Co.,limitedCentral Hong Kong, Hong KongExporter to the US, Manufacturer0000api.fda.gov
Forestadent Bernhard Forster GMBHPFORZHEIM Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Fseven Dental Technology Zhuhai Co.,ltdZHUHAI Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Great Lakes Dental Technologies, Ltd.Tonawanda, NY, United StatesContract manufacturer0000api.fda.gov
Hager & Werken GMBHDUISBURG,DE-NOTA Hamburg, GermanyManufacturer0000api.fda.gov
Hdi Inc.Seongnam-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Henan Baistra Medical Devices LimitedZhengzhou Henan, ChinaExporter to the US, Manufacturer0000api.fda.gov
Huanghua Promisee Dental Co., LtdHuanghua Hebei, ChinaManufacturer0000api.fda.gov
Hydroral SASAcigne Bretagne, FranceSpecification developer0000api.fda.gov
Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S.Konya, TurkeyManufacturer0000api.fda.gov
Inter-Med, Inc.Racine, WI, United StatesSpecification developer0000api.fda.gov
Jinyuan Medical Equipment(tianjin)co.,ltdTianjin, ChinaExporter to the US, Manufacturer0000api.fda.gov
Kerr CorporationOrange, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Keystone IndustriesMyerstown, PA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
M/S Leixir Resources Pvt. LtdGURUGRAM Haryana, IndiaManufacturer0000api.fda.gov
Practicon, Inc.Greenville, NC, United StatesSpecification developer0000api.fda.gov
Premium Plus (dongguan) LimitedDongguan Guangdong, ChinaManufacturer0000api.fda.gov
Shanghai Alwings Medical Instrument Co.,ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Showcase Dental Lab LLCPunta Gorda, FL, United StatesContract manufacturer, Contract sterilizer, Repackager or relabeler0000api.fda.gov
Sino-Vista Dental Instruments Co., Ltd.Zibo Shandong, ChinaContract manufacturer0000api.fda.gov
Suzhou Pac-Dent Technology Co., LtdSUZHOU CITY Jiangsu, ChinaContract manufacturer0000api.fda.gov
Tangshan Zhengtong Exhibition Co., Ltd.Tangshan Hebei, ChinaManufacturer0000api.fda.gov
Zhuhai Crystal Dental Technology Co.,ltdZhuhai Guangdong, ChinaManufacturer0000api.fda.gov
ZOGEAR Medical Co., Ltd.Yizheng Jiangsu, ChinaManufacturer0000api.fda.gov
iBrite Suzhou Technology Co., LtdSUZHOU CITY Jiangsu, ChinaContract manufacturer0000api.fda.gov

Updated January 23, 2004. 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.