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Data / Medical devices / Plate, Base, Shellac

Plate, Base, Shellac (EEA): 24 FDA-registered makers in 7 countries

24 establishments in 7 countries are registered with the FDA to make Plate, Base, Shellac (product code EEA, Class 1, 21 CFR 872.6200). 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 0 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
EEA
Device class
1
Regulation
872.6200
Medical specialty
Dental

Makers by country

CountryMakers
United States7
China6
Germany4
India2
Netherlands2
Pakistan2
Turkey1

Makers of Plate, Base, Shellac

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
Aadi Med Private LimitedDist. Palghar Maharashtra, IndiaContract manufacturer, Manufacturer0000api.fda.gov
Cavex Holland B.V.HAARLEM Noord-Holland, NetherlandsManufacturer0000api.fda.gov
Chaplet InternationalLahore Punjab, PakistanManufacturer0000api.fda.gov
Deltamed GMBHFRIEDBERG Hesse, GermanyManufacturer0000api.fda.gov
Dreve Dentamid GMBHUNNA North Rhine-Westphalia, GermanyManufacturer0000api.fda.gov
Guangzhou Heygears Imc.incGuangzhou Guangdong, ChinaSpecification developer0000api.fda.gov
Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S.Konya, TurkeyManufacturer0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer0000api.fda.gov
Jiangxi Heygears Innovative Material Co., LtdJiujiang Jiangxi, ChinaContract manufacturer0000api.fda.gov
Keystone IndustriesMyerstown, PA, United StatesManufacturer0000api.fda.gov
Keystone Industries - GibbstownGibbstown, NJ, United StatesManufacturer0000api.fda.gov
Luxcreo Inc.Chicago, IL, United StatesSpecification developer0000api.fda.gov
Ningbo Sezen Technology Co., Ltd.Ningbo Zhejiang, ChinaContract manufacturer0000api.fda.gov
Pac-Dent Inc.Brea, CA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Prevest Denpro LimitedJammu Jammu and Kashmir, IndiaManufacturer0000api.fda.gov
Pro3dure Medical GMBHIserlohn North Rhine-Westphalia, GermanyManufacturer0000api.fda.gov
Riton 3D Technology Co., LtdGuangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Stone Instruments Co.SIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Suzhou Laixin 3D Technology Co.,ltdSuzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shandong Huge Dental Material CorporationRizhao Shandong, ChinaManufacturer0000api.fda.gov
The Belport Company, Inc DBA Gingi-PakCamarillo, CA, United StatesManufacturer0000api.fda.gov
Vertex-Dental B.V.Soesterberg Utrecht, NetherlandsManufacturer0000api.fda.gov
Voco GMBHCUXHAVEN Lower Saxony, GermanyManufacturer0000api.fda.gov
Whip-Mix Corp.Louisville, KY, United StatesManufacturer0000api.fda.gov

Updated November 2, 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.