Home › Kerr Corporation › ZenFlex CM

ZenFlex CM

Kerr Corporation · Model 818-3691 · UDI-DI 00195062145773

EKS Prescription

510(k) clearances

3,963

Adverse events

Recalls

165

Facilities

Description

ZenFlex CM .06/21mm ASSORTED PACK US/CAN Contents: .13/.06/21mm ZenFlex CM NiTi FILE, GTIN 00195062145230, Qty 1 .15/.06/21mm ZenFlex CM NiTi FILE, GTIN 00195062145261, Qty 1 .17/.06/21mm ZenFlex CM NiTi FILE, GTIN 00195062145292, Qty 1 .20/.06/21mm ZenFlex CM NiTi FILE, GTIN 00195062145322, Qty 1 .25/.06/21mm ZenFlex CM NiTi FILE, GTIN 00195062145353, Qty 1 .30/.06/21mm ZenFlex CM NiTi FILE, GTIN 00195062145384, Qty 1

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 key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.