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Found 3 results
510(k) Data Aggregation
K Number
K123184Device Name
FINN CHAMBERS AQUA
Manufacturer
SMART PRACTICE
Date Cleared
2012-12-19
(70 days)
Product Code
KXF, LDH
Regulation Number
880.6025Why did this record match?
Applicant Name (Manufacturer) :
SMART PRACTICE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Finn Chambers AQUA is a patch test delivery system and holding device to place allergens and allergen mixes in contact with the surface of the skin during allergen patch tests. Finn Chambers AQUA patch test chambers are intended for use by, or under the supervision of, a physician for use as a patch test diagnostic device used in the testing of individuals suspected of having allergic or irritant contact dermatitis, photocontact dermatitis and experimental skin testing and allergy protocols.
Device Description
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K Number
K063160Device Name
ALLERGEAZE PATCH TEST CHAMBERS
Manufacturer
SMART PRACTICE
Date Cleared
2006-12-22
(66 days)
Product Code
KXF, LDH
Regulation Number
880.6025Why did this record match?
Applicant Name (Manufacturer) :
SMART PRACTICE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Allergen delivery system which provides a means to place allergens or allergen mixes in contact with the surface of the skin
Device Description
Not Found
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K Number
K023232Device Name
SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE
Manufacturer
SMART PRACTICE
Date Cleared
2002-12-11
(75 days)
Product Code
EFS
Regulation Number
872.6510Why did this record match?
Applicant Name (Manufacturer) :
SMART PRACTICE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SplatrFree Swangle 360 Disposable Prophy Angle is to be used during a prophylaxis treatment to polish the tooth surfaces of a patient.
Device Description
Not Found
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