Home › Device types › EKS
File, Pulp Canal, Endodontic
FDA product code EKS · Class 1 · Dental
13,700
Registered devices
3,984
Adverse events
3
Recalls
31
510(k) clearances
Devices with this code
MicroMega One RECI — MICRO MEGABrasseler USA — Peter Brasseler Holdings, LLCEndodontic Hand Instruments — TULSA DENTAL PRODUCTS LLCHealth-Tec/DHP Hedstrom Files — Dental Health Products Inc2Shape Mini — MICRO MEGAEdgeEndo — HSG-S Corp.Edge Morphology — US ENDODONTICS, LLCAvalon Biomed by Zarc BlueShaper PRO File 31mm (Z2) — NUSMILE, LTD.KOMET Root Canal Files — Gebr. Brasseler GmbH & Co. KGMANI RT FILES — MANI, INC.JIZAI — MANI, INC.MANI K-FILES — MANI, INC.EdgeSequel Sapphire — FKG Dentaire SàrlK-FILES — DiaDent Group InternationalH-FILES — DiaDent Group InternationalNITI K-FILES — TULSA DENTAL PRODUCTS LLCDCTAPER — Ss White Burs, Inc.Edge X7 Ultra — FKG Dentaire SàrlChannels — HENRY SCHEIN, INC.Integra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONIntegra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONProShape Conserve 04 Size 50 21MM — Endo Direct LLCDCTAPERH ROTARY FILE — MICRO MEGAEdge File — US ENDODONTICS, LLC
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.