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Gutta-Percha
FDA product code EKM · Class 1 · Dental
5,899
Registered devices
128
Adverse events
3
Recalls
23
510(k) clearances
Devices with this code
Top Quality Manufacturing — TOP QUALITY MANUFACTURING, INC.Zarc — Shanghai Xing Yu Medical Equipment Co.,Ltd.SCOTT'S GUTTA PERCHA PTS 120/bx CC # 90 — SCOTT'S DENTAL SUPPLY L.L.C.Brasseler USA — Peter Brasseler Holdings, LLCProcodile — SURE DENT CORPORATIONEXIMIA7 — Ss White Burs, Inc.MM MARKED GUTTA PERCHA POINTS — DiaDent Group InternationalGutta Percha 02-40 — Meta Biomed Co., Ltd.Gutta Percha Points — ROYDENT DENTAL PRODUCTS INCBrasseler USA — Peter Brasseler Holdings, LLCHenry Schein — HENRY SCHEIN, INC.GUTTA PERCHA POINTS — DiaDent Group InternationalHenry Schein — HENRY SCHEIN, INC.MG 02-15 LM — Meta Biomed Co., Ltd.Gutta Percha 06-LM-70 — Meta Biomed Co., Ltd.Advance Dental Products — The Atlanta Dental Supply CompanyGUTTA PERCHA POINTS — DiaDent Group InternationalMM MARKED GUTTA PERCHA POINTS — DiaDent Group InternationalHenry Schein — HENRY SCHEIN, INC.ProShape Gutta Percha ISO 40.04 — Endo Direct LLCGUTTA PERCHA POINTS — DiaDent Group InternationalEdgeCore for EdgeEvolve — US ENDODONTICS, LLCBrasseler USA — Peter Brasseler Holdings, LLCGutta Percha 04-50 — Meta Biomed Co., Ltd.
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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