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510(k) Data Aggregation
K Number
K983847Device Name
MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT
Manufacturer
Date Cleared
1998-12-01
(32 days)
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
GERMIPHENE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Odyssey ITM Dental Water unit with CAT filter is indicated for use as an in-line water disinfecting system to reduce microorganisms and particulate matter in the dental waterline.
Device Description
Odyssey ITM Dental Water unit
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K Number
K961289Device Name
VAPOPHENE
Manufacturer
Date Cleared
1997-12-04
(609 days)
Product Code
Regulation Number
880.6885Why did this record match?
Applicant Name (Manufacturer) :
GERMIPHENE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For use in sterilizing dental and surgical instruments such as extractor forceps with sirrated handles, IRIS scissors, and convex mirrors and handles, with all legally marketed models of MDT Harvey Chemiclaves, when use of chemiclave solution is indicated, and used according to the chemiclave cycle parameters, ( 132°C, 20 -27 psi, for 20 minutes per cycle). Not for use in water or steam type sterilizers
Device Description
Vapophene - Chemical autoclave solution
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K Number
K964796Device Name
ODYSSEY I DENTAL WATER UNIT
Manufacturer
Date Cleared
1997-05-14
(166 days)
Product Code
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
GERMIPHENE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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