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Data / Medical devices / Teeth, Porcelain

Teeth, Porcelain (ELL): 16 FDA-registered makers in 10 countries

16 establishments in 10 countries are registered with the FDA to make Teeth, Porcelain (product code ELL, Class 2, 21 CFR 872.3920). 9 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 39 510(k) clearances under this code, the latest on October 3, 2024, 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
ELL
Device class
2
Regulation
872.3920
Medical specialty
Dental

Makers by country

CountryMakers
United States5
China3
Sweden1
Switzerland1
Japan1
Liechtenstein1
Germany1
Vietnam1
Austria1
Israel1

Makers of Teeth, Porcelain

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
Nobel Biocare ABGOTEBORG Vastra Gotaland, SwedenSpecification developer2November 22, 2016000api.fda.gov
Nobel Biocare Services AGKloten Zurich, SwitzerlandSpecification developer2November 22, 2016000api.fda.gov
Shofu Inc.FUKUINE, HIGASHIYAMA-KU Kyoto, JapanManufacturer2July 14, 1989000api.fda.gov
Hangzhou Thales Medtech Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer1October 3, 2024000api.fda.gov
Ivoclar Vivadent AGSchaan, LiechtensteinSpecification developer1July 22, 1994000api.fda.gov
Keystone Dental Inc.Irvine, CA, United StatesManufacturer1May 22, 2006000api.fda.gov
Premier Dental Products Co.Plymouth Meeting, PA, United StatesSpecification developer1March 16, 1993000api.fda.gov
Vita Zahnfabrik H. Rauter GMBH & Co. KG.BAD SACKINGEN Baden-Wurttemberg, GermanyManufacturer1March 15, 1996000api.fda.gov
Xiao Fei Dental Manufacture (Chengdu) Co.LtdCHENGDU Sichuan, ChinaManufacturer1December 28, 1982000api.fda.gov
DENTAL LABORATORY MILLING SUPPLIES LLC (DLMS) / Digital DentalScottsdale, AZ, United StatesSpecification developer0000api.fda.gov
Ho Chi Minh Branch - Vatech Viet Joint Stock CompanyThanh My Tay Ward Ho Chi Minh, VietnamManufacturer0000api.fda.gov
Klema Dentalprodukte GMBHMeiningen Vorarlberg, AustriaManufacturer0000api.fda.gov
Nobel Biocare Procera, LLCMahwah, NJ, United StatesContract manufacturer0000api.fda.gov
Paltop Advanced Dental Solutions LtdCaesarea Central, IsraelContract manufacturer0000api.fda.gov
Silgan Unicep Packaging, LLC.Sandpoint, ID, United StatesContract manufacturer0000api.fda.gov
Shenzhen Jiahong Dental Technology Co., LtdShenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov

Updated October 3, 2024. 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.