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510(k) Data Aggregation
K Number
K053578Device Name
SCORPION ULTRASONIC SCALING INSERTS
Manufacturer
Date Cleared
2006-07-14
(204 days)
Product Code
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
SCORPION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Scorpion ultrasonic scaling inserts are used by dental professionals during dental cleaning procedures to remove supragingival calculus deposits from the teeth.
Device Description
The Scorpion ultrasonic scaling inserts are used by dental professionals during dental cleaning procedures to remove supragingival calculus deposits from teeth by application viennia. vienning. Scorpion manufactures several kinds of ultrasonic scaling inserts adaptable on different vitrasonic scalers. This notification concerns two inserts adaptable on piezo-electric scalers as follows: - BSA scaling insert, adaptable on SATELEC scalers handpieces. - BEM scaling insert, adaptable on EMS scalers handpieces. The Scorpion ultrasonic inserts have essentially the same internal design as the predicate devices.
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