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510(k) Data Aggregation
K Number
K191131Device Name
Solidence Multipockets
Manufacturer
Date Cleared
2022-08-03
(1192 days)
Product Code
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
Solidence Surgical Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Solidence Multipockets is a sterilization pouch intended to provide dentists with an effective method to enclose stainless steel dental burs of up to 0.5 grams intended for sterilization in steam autoclaves. The validated gravity steam sterilization cycle parameters are 10 minutes at 275°F (135°C), 30 minutes drying time, with a maximum weight of 18 grams, with no more than one bur in each pocket. The sterilization pockets maintain the sterility of the enclosed devices for one year post sterilization.
Device Description
The Solidence Multipockets is a single use sterilization pouch that features 36 pockets, designed to be used by dentists to enclose small medical devices intended for sterilization in steam autoclaves. The design of the Solidence Multipockets allows the dentists to sterilize 36 dental burs individually, using one sterilization pouch. Each pocket can then be opened independently, without compromising the sterility of the items contained in the other pockets of the sterilization pouch.
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