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510(k) Data Aggregation
K Number
K973765Device Name
BIO-2000
Manufacturer
Date Cleared
1998-11-04
(398 days)
Product Code
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
MICRYLIUM LABORATORIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For use in pressurized self-contained water devices.
For use in cleaning lines in dental units by leaving the solution (Bio2000), dispensed by a pressurized device, overnight (similar period of time) or use continuously. Cleaning lines refers to the reduction of microbial contamination.
For use in operative procedures to dedicated coolant (water) line for air or electric driven handpieces and scalers. Use of this device and solution will increase cutting efficiency and decrease the bad odors and tastes that occur during operative procedures while decreasing microbial contamination of the lubing.
Device Description
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