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510(k) Data Aggregation
K Number
K141854Device Name
INSTRUMENT CASSETTE (EFCCL1-F)
Manufacturer
Date Cleared
2015-10-29
(477 days)
Product Code
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
OSUNG MND CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
OSUNG INSTRUMENT CASSETTE (EFCCL1-F) is intended to hold instruments and accessories during storage and steam sterilization. This case cassette is intended to be used with a sterilized wrap in order to maintain sterility.
This case cassette is intended to be used with an FDA cleared sterilization wrap in order to maintain sterility.
Validated sterilization parameters:
| Cycle Type | Temperature | Exposure Time | Dry Time |
|---------------|--------------|---------------|------------|
| Gravity Steam | 132℃ (270°F) | 15 minutes | 30 minutes |
Device Description
The OSUNG INSTRUMENT CASSETTE is designed to handle reusable dental instruments for sterilization and storage. This device is intended to hold instruments and accessories during storage and steam sterilization, and to be used with a sterilized wrap in order to maintain sterility.
The OSUNG INSTRUMENT CASSETTE is comprised of a base, lid, silicone mat/rail, holders, and spring lock system.
The internal insert cassette has the ability to hold individualized pieces and accessories which include scissors, needle, elevators, forceps, pincers, retractors, mallets etc.
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