Home › Device types › EKS
File, Pulp Canal, Endodontic
FDA product code EKS · Class 1 · Dental
13,388
Registered devices
3,925
Adverse events
3
Recalls
31
510(k) clearances
Devices with this code
KOMET Root Canal Files — Gebr. Brasseler GmbH & Co. KGProTaper Universal Hand Files — TULSA DENTAL PRODUCTS LLCHenry Schein — HENRY SCHEIN, INC.Edge Morphology — US ENDODONTICS, LLCBrasseler USA — Peter Brasseler Holdings, LLCX-Factor™ Minimally Invasive NiTi Files 25/.03 (21mm) — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.REAMERS — DiaDent Group InternationalJMU — JMU DENTAL, INCJMU — JMU DENTAL, INCProFile GT Rotary File — TULSA DENTAL PRODUCTS LLCChannels — HENRY SCHEIN, INC.EXACTTAPERH DC — Ss White Burs, Inc.FlowLogic Agile — SONENDO, INC.Endodontic Hand Instruments — TULSA DENTAL PRODUCTS LLCJMU — JMU DENTAL, INCKP — Guilin Kevin Peter Technology Co., Ltd.ZARC — Shenzhen Denco Medical Co., LtdDCTAPER — Ss White Burs, Inc.NAVITAPER GOLD NITI FILES 6/pk VT 25mm # C1 — SCOTT'S DENTAL SUPPLY L.L.C.Easy Bassi — EASY EQUIPAMENTOS ODONTOLOGICOS LTDA.Safco Maxim K Files and Hedstrom — SAFCO DENTAL SUPPLY CO.Edge File — US ENDODONTICS, LLCEXACTTAPER — Ss White Burs, Inc.HEDSTROM FILES — DiaDent Group International
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-01-02 | US Endodontics, LLC | Due to devices being irradiated above the established specification which my result in package integrity issues. |
| 2012-12-12 | Ormco/Sybronendo | The length markings on the Lightspeed LSX files were wrong. |
| 2008-08-01 | Ormco Corporation | A recall was initiated because SybronEndo has confirmed that the K3 Engine File G-Pack has label packaging and file mis-marking error. |
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