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510(k) Data Aggregation
K Number
K012914Device Name
SONICWAVE SONIC PLAQUE REMOVER
Manufacturer
HOMEDICS, INC.
Date Cleared
2001-10-01
(32 days)
Product Code
JEQ
Regulation Number
872.6865Why did this record match?
Applicant Name (Manufacturer) :
HOMEDICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Operates at over 30,000 strokes per minute to help remove plaque bacteria ●
- Sonic waves penetrate beyond the bristle tips, for superior cleaning. .
- Ergonomic design with rubberized Comfort-Grip surface. .
- Two-minute timer helps ensure dentist recommended brush time. .
Device Description
This 2.4 volt rechargeable battery operated toothbrush is a sonic wave plaque remover with rapidly vibrating bristles that penetrate the most difficult-to-clean areas of your mouth - Places your standard toothbrush might miss. It's also gentle, with seven speeds you can adjust to your own sensitivity level. This effective combination of ergonomics and technology brings you an easy, everyday way to prevent tooth decay and gum disease.
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K Number
K001860Device Name
PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA
Manufacturer
HOMEDICS, INC.
Date Cleared
2000-08-10
(52 days)
Product Code
IMC
Regulation Number
890.5110Why did this record match?
Applicant Name (Manufacturer) :
HOMEDICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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