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Data / Medical devices / Post, Root Canal

Post, Root Canal (ELR): 62 FDA-registered makers in 13 countries

62 establishments in 13 countries are registered with the FDA to make Post, Root Canal (product code ELR, Class 1, 21 CFR 872.3810). 8 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 35 510(k) clearances under this code, the latest on March 30, 2006, and lists 2 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.

Product code
ELR
Device class
1
Regulation
872.3810
Medical specialty
Dental

Makers by country

CountryMakers
United States15
China9
Germany9
Switzerland6
Italy5
France4
Sweden4
Brazil3
South Korea2
Mexico2
Finland1
Vietnam1
India1

Makers of Post, Root Canal

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
Coltene/Whaledent Inc.Cuyahoga Falls, OH, United StatesManufacturer3April 14, 2000010api.fda.gov
AnthogyrSALLANCHES Haute-Savoie, FranceManufacturer1July 3, 2002000api.fda.gov
Kerr CorporationPomona, CA, United StatesManufacturer1November 9, 1998000api.fda.gov
Kerr CorporationPomona, CA, United StatesManufacturer, Repackager or relabeler1November 9, 1998000api.fda.gov
Kerr Italia, S.r.l.SCAFATI Salerno, ItalyManufacturer1November 9, 1998000api.fda.gov
Stick Tech Ltd.TURKU Pirkanmaa, FinlandComplaint file establishment, Manufacturer1May 20, 2003000api.fda.gov
Sterngold Dental LLCAttleboro, MA, United StatesManufacturer1March 23, 1995000api.fda.gov
Zest Anchors, LLCCarlsbad, CA, United StatesRepackager or relabeler, Specification developer1October 10, 2001000api.fda.gov
Abrasive Technology, LLCLewis Center, OH, United StatesManufacturer0000api.fda.gov
Angelus Industria De Productos OdontologicosLONDRINA Parana, BrazilManufacturer0000api.fda.gov
B&L Biotech Co., IncAnsan City Gyeonggi, South KoreaManufacturer0000api.fda.gov
Bio Composants Medicaux (BCM)SAINT BLAISE DU BUIS Isere, FranceContract manufacturer, Manufacturer0000api.fda.gov
Bioloren SRLSARONNO Varese, ItalyManufacturer0000api.fda.gov
Brasseler U.S.A. Dental, LLCSavannah, GA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Cendres+metaux SABiel/Bienne Bern, SwitzerlandManufacturer0000api.fda.gov
Cenova ABMJOLBY Ostergotland, SwedenContract manufacturer0000api.fda.gov
Cynosure, LLCWestford, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
D.S.P. Industrial Eireli EppCampo Largo Parana, BrazilManufacturer0000api.fda.gov
Debo Medical Technology (shijiazhuang) Co., Ltd.Shijiazhuang Hebei, ChinaContract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Dent4you AGHeerbrugg Sankt Gallen, SwitzerlandSpecification developer0000api.fda.gov
Dentatus ABSPANGA Stockholm, SwedenManufacturer0000api.fda.gov
Dentscare LtdaJoinville Santa Catarina, BrazilManufacturer0000api.fda.gov
Dentsply LLCMilford, DE, United StatesManufacturer0000api.fda.gov
Directa ABUPPLANDS VAESBY Stockholm, SwedenManufacturer, Repackager or relabeler0000api.fda.gov
DMG Chemisch Pharmazeutische Fabrik GMBHHamburg, GermanyManufacturer0000api.fda.gov
Digital Age Dental Laboratories, Ltd.Vinh Tan Ward Ho Chi Minh, VietnamExporter to the US, Manufacturer0000api.fda.gov
E. Hahnenkratt GMBHKOENIGSBACH-STEIN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Essential Dental Systems, Inc.S Hackensack, NJ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Gebr. Brasseler GMBH & Co. KGLEMGO North Rhine-Westphalia, GermanyContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Harald Nordin S.A.Montreux Vaud, SwitzerlandManufacturer0000api.fda.gov
High Point Precision ProductsSussex, NJ, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Hubei Guarddent Medical Technology Co.,ltdWuhan Hubei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Henan Lusterdent Medical Instrument Co.,LtdZhengzhou Henan, ChinaManufacturer0000api.fda.gov
Hipp Medical AGRenquishausen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Ilumi Sciences IncChantilly, VA, United StatesManufacturer0000api.fda.gov
Inno Dental Co., Ltd.Seoul, South KoreaManufacturer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesManufacturer0000api.fda.gov
Itena Clinical VillepinteVillepinte Seine-Saint-Denis, FranceSpecification developer0000api.fda.gov
J C IndiaRajkot Gujarat, IndiaManufacturer0000api.fda.gov
Maillefer Instruments Holding SarlBALLAIGUES Vaud, SwitzerlandManufacturer, Repackager or relabeler0000api.fda.gov
Micerium S.P.A.AVEGNO Genova, ItalyManufacturer0000api.fda.gov
Nti-Kahla GMBH, Rotary Dental InstrumentsKAHLA Thuringia, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
Overfibers S.R.LIMOLA Bologna, ItalyComplaint file establishment, Manufacturer0000api.fda.gov
Polydentia S.A.MEZZOVICO-Vira Ticino, SwitzerlandManufacturer0000api.fda.gov
Premier Dental Products Co.Plymouth Meeting, PA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Produits Dentaires SAVEVEY (SUISSE) Vaud, SwitzerlandManufacturer0000api.fda.gov
Recherches Techniques Dentaires (R.T.D.)ST. EGREVE Isere, FranceContract manufacturer, Manufacturer0000api.fda.gov
Rhein 83 SRLBOLOGNA Emilia-Romagna, ItalyComplaint file establishment, Manufacturer0000api.fda.gov
SDS de Mexico S. de R.L. de C.V.MEXICALI, B.C. C.P. Baja California, MexicoContract manufacturer0000api.fda.gov
Shanghai Alwings Medical Instrument Co.,ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Shanghai Fanta Dental Materials Co., Ltd.Shanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shenzhen Denco Medical Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Shenzhen Forever Medical Devices Co., LtdShenzhen Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Shenzhen Rogin Medical Co., Ltdshenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Svenska Dentorama ABSOLLENTUNA Stockholm, SwedenManufacturer0000api.fda.gov
Solventum Germany GmbHKamen North Rhine-Westphalia, GermanyComplaint file establishment, Specification developer0000api.fda.gov
Solventum Germany GmbHSEEFELD Bavaria, GermanyManufacturer0000api.fda.gov
Symmetry Surgical GmbHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Voco GMBHCUXHAVEN Lower Saxony, GermanyRepackager or relabeler, Specification developer0000api.fda.gov
Zest Anchors, LLCEscondido, CA, United StatesManufacturer0000api.fda.gov
ZOGEAR Medical Co., Ltd.Yizheng Jiangsu, ChinaManufacturer0000api.fda.gov

Updated March 30, 2006. 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.