FDA Device Intelligence
Home › Device types › EKR

Plugger, Root Canal, Endodontic

FDA product code EKR · Class 1 · Dental

1,218
Registered devices
71
Adverse events
3
Recalls
6
510(k) clearances

Devices with this code

Integra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONIntegra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHU-FRIEDY — HU-FRIEDY MFG. CO., LLCBrasseler USA — Peter Brasseler Holdings, LLCBrasseler USA — Peter Brasseler Holdings, LLCHU-FRIEDY — HU-FRIEDY MFG. CO., LLCHU-FRIEDY — HU-FRIEDY MFG. CO., LLCHU-FRIEDY — HU-FRIEDY MFG. CO., LLCObtura Spartan — Young Innovations, Inc.HU-FRIEDY — HU-FRIEDY MFG. CO., LLCEdgeFlow™ — US ENDODONTICS, LLCNeedle — B& L Biotech, inc.ROOT CANAL INSTRUMENT — KLS-Martin L.P.Power Dental USA — Power Dental U.S.A. Inc.Advanced Dental System — ASI MEDICAL, INC.Hu-Friedy — HU-FRIEDY MFG. CO., LLCPower Dental USA — Power Dental U.S.A. Inc.J & J INSTRUMENTS — J & J INSTRUMENTS INCHU-FRIEDY — HU-FRIEDY MFG. CO., LLCJ & J INSTRUMENTS — J & J INSTRUMENTS INCDUO-PEN — DiaDent Group InternationalEQ-V — META SYSTEMS CO., LTD.EQ-V — META SYSTEMS CO., LTD.Hu-Friedy — HU-FRIEDY MFG. CO., LLC

Recent recalls

DateFirmReason
2017-12-27Ormco/SybronendoBuchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU).
2013-01-17Ormco/SybronendoA recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the Ele
2013-01-17Ormco/SybronendoA recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the Ele

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 docs
Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.