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510(k) Data Aggregation
K Number
K163414Device Name
Ultrasonic scaler
Manufacturer
NANNING VV DENTAL CO., LTD.
Date Cleared
2017-11-21
(351 days)
Product Code
ELC
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
NANNING VV DENTAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ultrasonic scaler is intended to:
1. Remove supra and sub gingival calculus deposits and stain from the teeth;
2. Carry out periodontal pocket lavage with simultaneous ultrasonic tip movement;
3. Clean and irrigate root canals
Device Description
The Ultrasonic scaler employs piezoelectric technology to produce a steady power. It is composed of a control unit housing a generator that produces piezo-electric vibrations. The working instrument for the ultrasonic scaler is the handpiece, which is connected to the control unit via a handpiece cord. A scaling tip specific to a particular procedure is attached to the end of the handpiece. The ultrasonic scaler models VET-W3 and VST-W3 connect to an external water supply and delivers water via connected handpiece.
Ultrasonic scaler consists of main generator, VE and VS handpiece, optional scaler tips (G series, P series, E series), power adapter and foot switch;
The main part is as follows:
1. Power adapter: DC 24V, input frequency: 3-20W
2. Main engine: The main engine is the major part of the circuit control, including ultrasonic pulse circuit, modulator circuit and oscillatory circuit. It is used for converting the ultrasonic oscillatory signal to ultrasonic mechanical oscillatory signal by magnifying and improving the vibrating frequency.
3. Handpiece: It mainly converts the signal from circuit,which will drive the ultrasonic scaler tips vibrating.
4. Scaler tip: The scaler tip is used to remove the calculus and plague by vibrating on the teeth surface.
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