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510(k) Data Aggregation
K Number
K233918Device Name
Dental Barrier and Sleeves
Manufacturer
Yongqing Huaguan Dental Instruments Factory
Date Cleared
2024-05-09
(148 days)
Product Code
PEM
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
Yongqing Huaguan Dental Instruments Factory
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dental Barrier and Sleeves 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
Dental Barrier and Sleeves consist of various sizes and shapes of 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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