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Found 4 results
510(k) Data Aggregation
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?
Product Code :
EFS
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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K Number
K001493Device Name
DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001
Manufacturer
AIR FORCE, INC.
Date Cleared
2000-10-25
(166 days)
Product Code
EFS
Regulation Number
872.6510Why did this record match?
Product Code :
EFS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K983374Device Name
AGATHA-A-H2010
Manufacturer
MIDIAN INTL.
Date Cleared
1998-12-23
(89 days)
Product Code
EFS
Regulation Number
872.6510Why did this record match?
Product Code :
EFS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To Remove adherent plaque and debris from the teeth and oral mucosa, to Reduce tooth decay in patients who are Physically unable to perform brushing. To Prevent Aspiration, which may be associated with mechanical brushing only in these patients.
Device Description
Not Found
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K Number
K964810Device Name
DERMADAM
Manufacturer
ULTRADENT PRODUCTS, INC.
Date Cleared
1997-02-10
(73 days)
Product Code
EFS
Regulation Number
872.6510Why did this record match?
Product Code :
EFS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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