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Gutta-Percha
FDA product code EKM · Class 1 · Dental
5,974
Registered devices
129
Adverse events
3
Recalls
23
510(k) clearances
Devices with this code
Midway Select — MIDWAY DENTAL SUPPLY, LLCIntegra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONIntegra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONSure-endo — SURE DENT CORPORATIONProShape Gutta Percha ISO 20.06 — Endo Direct LLCEdge X7 GP — SURE DENT CORPORATIONEdgeFile® — US ENDODONTICS, LLCZarc — Shanghai Xing Yu Medical Equipment Co.,Ltd.Top Quality Manufacturing — TOP QUALITY MANUFACTURING, INC.GP Pts: Greater Taper 08 — TULSA DENTAL PRODUCTS LLCHenry Schein — HENRY SCHEIN, INC.Zarc — Shanghai Xing Yu Medical Equipment Co.,Ltd.Zarc — Shanghai Xing Yu Medical Equipment Co.,Ltd.HyFlex™ Guttapercha Points — Coltène/Whaledent GmbH + Co. KGEdgeV-File HT™ — US ENDODONTICS, LLCEdgeEndo® — US ENDODONTICS, LLCGUTTA PERCHA POINTS — DiaDent Group InternationalMM MARKED GUTTA PERCHA POINTS — DiaDent Group InternationalMM MARKED GUTTA PERCHA POINTS — DiaDent Group InternationalGUTTA PERCHA POINTS — DiaDent Group InternationalDarby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLCMM MARKED GUTTA PERCHA POINTS — DiaDent Group InternationalGUTTA PERCHA POINTS — DiaDent Group International3D Endo — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-02-08 | Ormco/Sybronendo | Ormco Corporation is recalling the TF Adaptive Gutta Percha Point Size SM3-50pk because the inner generic label is identified as ML3. The products outer packag |
| 2010-09-09 | Ormco Corporation | The recall was initiated because SybronEndo has confirmed that the Microseal Master Cones has been mislabeled. |
| 2009-10-27 | Sybronendo | The recall was initiated because during the manufacturing process of the affected units, the molding process resulted in lock nuts that did not have the level o |
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