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510(k) Data Aggregation
K Number
K190484Device Name
BH Medical Dental Barrier Sleeves and Barrier Film
Manufacturer
BH Medical Products Co., Ltd.
Date Cleared
2019-09-10
(195 days)
Product Code
PEM
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
BH Medical Products Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BH Medical Dental Barrier Sleeves and Barrier Film are intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.
Device Description
BH Medical Dental Barrier Sleeves and Barrier Film consist of various sizes and shapes of clear polyethylene covers which are positioned on various small hand-held dental instruments such as hand pieces, curing lights, air/water syringes and similar hand instruments. In other forms, they are used to cover various devices such as dental chairs, dental instrument trays, x-ray heads, and others. The products are sold non-sterile, prepackaged, and are disposable, single use only.
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K Number
K172280Device Name
BH Sterilization Pouch
Manufacturer
BH Medical Products Co., Ltd.
Date Cleared
2018-08-03
(371 days)
Product Code
FRG, JOJ, KCT
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
BH Medical Products Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BH sterilization pouch is intended to provide dentists with an effective method to enclose devices intended for sterilization in steam auto claves. The recommended pre-vacuum steam sterilization cycle parameters are 4 minutes at 132°C (270°F). The sterilization pouch maintains the enclosed devices up until 180 days post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the pouch has undergone a steam sterilization process. Only one instrument can be sterilized in one pouch and only instruments that are be metal, hinged, or knurled can be sterilized in the pouch.
Device Description
The pouches are made from a medical grade paper and plastic film that is heat sealed on three sides. The forth side has an adhesive strip that is used to seal the paper to the film prior to sterilization of the enclosed medical device. The medical grade paper conforms to recognized material standards and can be steam sterilized. The process indicator ink printed on the medical paper will exhibit a color change after the pouch is exposed to steam sterilization. The device is disposable, single use only.
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