FDA Device Intelligence
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Plugger, Root Canal, Endodontic

FDA product code EKR · Class 1 · Dental

1,196
Registered devices
71
Adverse events
3
Recalls
6
510(k) clearances

Devices with this code

Hu-Friedy — HU-FRIEDY MFG. CO., LLCIntegra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHU-FRIEDY — HU-FRIEDY MFG. CO., LLCHU-FRIEDY — HU-FRIEDY MFG. CO., LLCMANI PLUGGERS — MANI, INC.HU-FRIEDY — HU-FRIEDY MFG. CO., LLCAdvanced Endodontic System — ASI MEDICAL, INC.elements IC — META SYSTEMS CO., LTD.EDGE ENDO — HANDPIECE PARTS & REPAIRS, INC.BURKHART DENTAL — NORDENT MANUFACTURING INCPower Dental U.S.A., Inc. — Power Dental U.S.A. Inc.JEDMED — JEDMED INSTRUMENT COMPANYBrasseler USA — Peter Brasseler Holdings, LLCHU-FRIEDY — HU-FRIEDY MFG. CO., LLCIntegra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONIntegra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONPower Dental USA — Power Dental U.S.A. Inc.HELMUT ZEPF — Helmut Zepf Medizintechnik GmbHJEDMED — JEDMED INSTRUMENT COMPANYBrasseler USA — Peter Brasseler Holdings, LLCOSUNG MND — OSUNG MND Co., Ltd.HU-FRIEDY — HU-FRIEDY MFG. CO., LLCDarby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLCGPRO — Beyes Dental Canada Inc

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

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