FDA Device Intelligence
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Explorer, Operative

FDA product code EKB · Class 1 · Dental

1,149
Registered devices
14
Adverse events
7
Recalls
3
510(k) clearances

Devices with this code

Sklar® — SKLAR CORPORATIONNivo — B. Ali ImpexHenry Schein — HENRY SCHEIN, INC.BURKHART DENTAL — NORDENT MANUFACTURING INCHU-FRIEDY — HU-FRIEDY MFG. CO., LLCHELMUT ZEPF — Helmut Zepf Medizintechnik GmbHNORDENT MANUFACTURING INC — NORDENT MANUFACTURING INCBrasseler USA — Peter Brasseler Holdings, LLCIntegra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONNORDENT MANUFACTURING INC — NORDENT MANUFACTURING INCPrecision Dental Instruments — Precision Dental InstrumentsHU-FRIEDY — HU-FRIEDY MFG. CO., LLCBURKHART DENTAL — NORDENT MANUFACTURING INCNORDENT MANUFACTURING INC — NORDENT MANUFACTURING INCHU-FRIEDY — HU-FRIEDY MFG. CO., LLCPDT, Inc. — PDT, INC.NORDENT MANUFACTURING INC — NORDENT MANUFACTURING INCNORDENT MANUFACTURING INC — NORDENT MANUFACTURING INCBURKHART DENTAL — NORDENT MANUFACTURING INCEXPLORER — KLS-Martin L.P.Premier Explorers — PREMIER DENTAL PRODUCTS COMPANYEXPLORER — KLS-Martin L.P.HU-FRIEDY — HU-FRIEDY MFG. CO., LLCSklar® — SKLAR CORPORATION

Recent recalls

DateFirmReason
2005-01-07Hu-Friedy Mfg Co, Inc.Potential for tip breakage at the terminal shank due to improper heat-treatment at the foreign plant. Several reports of tip breakage were received by the own
2005-01-07Hu-Friedy Mfg Co, Inc.Potential for tip breakage at the terminal shank due to improper heat-treatment at the foreign plant. Several reports of tip breakage were received by the own
2005-01-07Hu-Friedy Mfg Co, Inc.Potential for tip breakage at the terminal shank due to improper heat-treatment at the foreign plant. Several reports of tip breakage were received by the own
2005-01-07Hu-Friedy Mfg Co, Inc.Potential for tip breakage at the terminal shank due to improper heat-treatment at the foreign plant. Several reports of tip breakage were received by the own
2004-03-29Hu-Friedy Mfg Co, Inc.Reports of breakage on some dental explorers were received by the own label distributor and forwarded to Hu-Friedy Mfg. Co. (importer of record & Spec. Setter).
2004-03-29Hu-Friedy Mfg Co, Inc.Reports of breakage on some dental explorers were received by the own label distributor and forwarded to Hu-Friedy Mfg. Co. (importer of record & Spec. Setter).
2004-03-29Hu-Friedy Mfg Co, Inc.Reports of breakage on some dental explorers were received by the own label distributor and forwarded to Hu-Friedy Mfg. Co. (importer of record & Spec. Setter).

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