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
| Country | Makers |
|---|---|
| United States | 15 |
| China | 9 |
| Germany | 9 |
| Switzerland | 6 |
| Italy | 5 |
| France | 4 |
| Sweden | 4 |
| Brazil | 3 |
| South Korea | 2 |
| Mexico | 2 |
| Finland | 1 |
| Vietnam | 1 |
| India | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Coltene/Whaledent Inc. | Cuyahoga Falls, OH, United States | Manufacturer | 3 | April 14, 2000 | 0 | 1 | 0 | api.fda.gov |
| Anthogyr | SALLANCHES Haute-Savoie, France | Manufacturer | 1 | July 3, 2002 | 0 | 0 | 0 | api.fda.gov |
| Kerr Corporation | Pomona, CA, United States | Manufacturer | 1 | November 9, 1998 | 0 | 0 | 0 | api.fda.gov |
| Kerr Corporation | Pomona, CA, United States | Manufacturer, Repackager or relabeler | 1 | November 9, 1998 | 0 | 0 | 0 | api.fda.gov |
| Kerr Italia, S.r.l. | SCAFATI Salerno, Italy | Manufacturer | 1 | November 9, 1998 | 0 | 0 | 0 | api.fda.gov |
| Stick Tech Ltd. | TURKU Pirkanmaa, Finland | Complaint file establishment, Manufacturer | 1 | May 20, 2003 | 0 | 0 | 0 | api.fda.gov |
| Sterngold Dental LLC | Attleboro, MA, United States | Manufacturer | 1 | March 23, 1995 | 0 | 0 | 0 | api.fda.gov |
| Zest Anchors, LLC | Carlsbad, CA, United States | Repackager or relabeler, Specification developer | 1 | October 10, 2001 | 0 | 0 | 0 | api.fda.gov |
| Abrasive Technology, LLC | Lewis Center, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Angelus Industria De Productos Odontologicos | LONDRINA Parana, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B&L Biotech Co., Inc | Ansan City Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bio Composants Medicaux (BCM) | SAINT BLAISE DU BUIS Isere, France | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioloren SRL | SARONNO Varese, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Brasseler U.S.A. Dental, LLC | Savannah, GA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cendres+metaux SA | Biel/Bienne Bern, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cenova AB | MJOLBY Ostergotland, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cynosure, LLC | Westford, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| D.S.P. Industrial Eireli Epp | Campo Largo Parana, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Debo Medical Technology (shijiazhuang) Co., Ltd. | Shijiazhuang Hebei, China | Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dent4you AG | Heerbrugg Sankt Gallen, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentatus AB | SPANGA Stockholm, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentscare Ltda | Joinville Santa Catarina, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentsply LLC | Milford, DE, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Directa AB | UPPLANDS VAESBY Stockholm, Sweden | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| DMG Chemisch Pharmazeutische Fabrik GMBH | Hamburg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Digital Age Dental Laboratories, Ltd. | Vinh Tan Ward Ho Chi Minh, Vietnam | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| E. Hahnenkratt GMBH | KOENIGSBACH-STEIN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Essential Dental Systems, Inc. | S Hackensack, NJ, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gebr. Brasseler GMBH & Co. KG | LEMGO North Rhine-Westphalia, Germany | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Harald Nordin S.A. | Montreux Vaud, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| High Point Precision Products | Sussex, NJ, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei Guarddent Medical Technology Co.,ltd | Wuhan Hubei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Henan Lusterdent Medical Instrument Co.,Ltd | Zhengzhou Henan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hipp Medical AG | Renquishausen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ilumi Sciences Inc | Chantilly, VA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inno Dental Co., Ltd. | Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrias Apson S.A de C.V | AGUA PRIETA Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra LifeSciences Production Corporation | Mansfield, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Itena Clinical Villepinte | Villepinte Seine-Saint-Denis, France | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J C India | Rajkot Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maillefer Instruments Holding Sarl | BALLAIGUES Vaud, Switzerland | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micerium S.P.A. | AVEGNO Genova, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nti-Kahla GMBH, Rotary Dental Instruments | KAHLA Thuringia, Germany | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Overfibers S.R.L | IMOLA Bologna, Italy | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Polydentia S.A. | MEZZOVICO-Vira Ticino, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Premier Dental Products Co. | Plymouth Meeting, PA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Produits Dentaires SA | VEVEY (SUISSE) Vaud, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Recherches Techniques Dentaires (R.T.D.) | ST. EGREVE Isere, France | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rhein 83 SRL | BOLOGNA Emilia-Romagna, Italy | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SDS de Mexico S. de R.L. de C.V. | MEXICALI, B.C. C.P. Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Alwings Medical Instrument Co.,ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Fanta Dental Materials Co., Ltd. | Shanghai, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Denco Medical Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Forever Medical Devices Co., Ltd | Shenzhen Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Rogin Medical Co., Ltd | shenzhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Svenska Dentorama AB | SOLLENTUNA Stockholm, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum Germany GmbH | Kamen North Rhine-Westphalia, Germany | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum Germany GmbH | SEEFELD Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Surgical GmbH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Voco GMBH | CUXHAVEN Lower Saxony, Germany | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zest Anchors, LLC | Escondido, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ZOGEAR Medical Co., Ltd. | Yizheng Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.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.