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510(k) Data Aggregation
K Number
K220346Device Name
Lotus Prophy Angle
Manufacturer
AJK Engineering, Inc.
Date Cleared
2022-11-07
(273 days)
Product Code
EGS
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
AJK Engineering, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Lotus Prophy Angle is for polishing and cleaning teeth.
Device Description
Lotus Prophy Angle is a device used for polishing and cleaning the surface of teeth. It consists of a pair of gears, a turning spindle and a drive spindle which can connect the low speed handpiece. The turning spindle has a prophylaxis cup on it for polishing or cleaning teeth.
Lotus Prophy Angle is intended for single use only and is provided aseptic in sealed packaging to be prevent contamination.
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