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510(k) Data Aggregation
K Number
K033925Device Name
BIOFREE
Manufacturer
Date Cleared
2004-04-07
(111 days)
Product Code
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
DENTAL COMPONENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
BIOFREE INHIBITS AND CONTROLS THE GROWTH OF BACTERIA, BIOFILM, ENDOTOXINS, FUNGUS, AND ALGAE PROVIDING ANTIMICROBIAL SURFACE IS REGENERATED WITH THE CONTINUOUS USE OF A STERISIL WATER PRE-TREATMENT PRODUCT. BIOFREE IS INTENDED TO BE USED WITH DISTILLED, DEIONIZED, OR REVERSE OSMOSIS WATER. EFFICACY FOR TAP WATER HAS NOT BEEN DETERMINED. THIS PRODUCT IS NOT INTENDED TO PROVIDE STERILE WATER.
Device Description
BIO-FREE TUBING AND BOTTLE FOR DENTAL OPERATIVE UNIT
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K Number
K971727Device Name
DCI WATER PURIFIER
Manufacturer
Date Cleared
1997-09-12
(126 days)
Product Code
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
DENTAL COMPONENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A device which provides water exposed Ultraviolet for a denta ( conjunction wit operate treatment devices, to veduce Water bacteria in the water number o
Device Description
Not Found
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