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510(k) Data Aggregation
K Number
K140233Device Name
ULTRASONIC SCALER
Manufacturer
NANNING BAOLAI MEDICAL INSTRUMENT CO., LTD.
Date Cleared
2015-04-06
(431 days)
Product Code
ELC
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
NANNING BAOLAI MEDICAL INSTRUMENT 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
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 connects to an external water supply and delivers water via connected handpiece.
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