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510(k) Data Aggregation
K Number
K150076Device Name
Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L
Manufacturer
Date Cleared
2015-06-02
(139 days)
Product Code
Regulation Number
872.4120Why did this record match?
Applicant Name (Manufacturer) :
DONG IL TECHNOLOGY LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L are piezoelectric devices for surgery that enable mechanical ultrasound treatment, osteotomy and osteoplasty techniques to be applied in dental use.
Device Description
Sonic Surgeon 310L. Sonic Surgeon 600L and Sonic Surgeon 800L are ultrasonic surgical units intended for mechanical ultrasound treatment in prophylaxis, periodontics. The normal mode is tooth scaling applications, and the Boost Mode of Sonic Surgeon 310L. Sonic Surgeon 600L and Sonic Surgeon 800L can be used for surgical procedures, including osteotomy, osteoplasty, periodontal surgery and implantation.
The tips can easily be changed during the treatment and must also be cleaned and autoclaved.
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K Number
K110881Device Name
ULTRASONIC SURGICAL UNIT
Manufacturer
Date Cleared
2011-12-16
(261 days)
Product Code
Regulation Number
872.4120Why did this record match?
Applicant Name (Manufacturer) :
DONG IL TECHNOLOGY LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Ultrasonic Surgical Unit is a piczoelectric device for bone surgery that enables ostcotomy and ostcoplasty techniques to be applied to in dental use.
Device Description
Sonic Surgeon 300 is an ultrasound generator for use in dental surgery. And this device is used for surgical procedures, including osteonal surgery and in device your and implantation. Boost Mode can be used for mechanical ultrasound treatment in prophylaxis, periodontics or endodontics. The tips can easily be changed during the treatment and can also be cleaned and autoclaved. The Ultrasonic Surgical Unit transforms generated ultrasonic (26±3kHz) energy to the kinetic energy and transmits it to the tip. The generator of the Ultrasonic Surgical Unit performs automatic tuning of the operating frequency, the efficiency of the piezoelectric transducer in the handpiece.
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