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        "productCode": "MMP",
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        "initiated": "2015-02-11",
        "reason": "Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes  labeled with part number 4500 which fit 7mm and 8mm tips.  There is a low risk associated with the use of the product as the sleeve may tear causing a potential for cross contamination."
      },
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        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2013-06-06",
        "reason": "The firm initiated the recall of AOA Mini RPE Screw Assembly, because it may be missing a complete weld joining one side of the arm with the screw body. Herbst, MARA and Fixed Metal devices may be affected, because they contain an AOA Mini RPE Screw Assembly."
      },
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        "resNumber": "Z-0989-2012",
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        "status": "Terminated",
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        "initiated": "2011-03-03",
        "reason": "The recall was initiated because Pentron Clinical has confirmed that the Flow Tec Nano-Hybrid Flowable Composite material has been found to be difficult to extrude."
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      {
        "resNumber": "Z-0990-2012",
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        "reason": "The recall was initiated because Pentron Clinical has confirmed that the Flow Tec Nano-Hybrid Flowable Composite material has been found to be difficult to extrude."
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        "initiated": "2010-11-04",
        "reason": "Pentron Clinical is voluntarily recalling the following lot of mislabeled Correct VPS Medium Body Tubes.  It was discovered that the individual tubes inside the Correct VPS Medium Body Tube boxes are missing the lot/expiration date sticker."
      }
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      "code": "EBZ",
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      "code": "EFB",
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      "code": "EIA",
      "deviceName": "Unit, Operative Dental",
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      "code": "EKS",
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      "code": "KCT",
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    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Sybron%20Dental%20Specialties%22",
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}
