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510(k) Data Aggregation
K Number
K091227Device Name
PIEZOSURGERY 3; OSSTEM PIEZO
Manufacturer
PIEZOSURGERY S.R.L.
Date Cleared
2009-12-29
(245 days)
Product Code
DZI, ELC
Regulation Number
872.4120Why did this record match?
Applicant Name (Manufacturer) :
PIEZOSURGERY S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OSSTEMPiezo is intended for use in the following dental applications:
- Bone cutting for use in oral surgery
- Removing supra and subgingival calculus deposits and stains from teeth
- Periodontal pocket lavage with simultaneous ultrasonic tip movement
- Scaling and root planing
- Retrograde preparation of root canals
The Piezosurgery 3 is intended for use in the following dental applications:
- Bone cutting for use in oral surgery
- Removing supra and subgingival calculus deposits and stains from teeth
- Periodontal pocket lavage with simultaneous ultrasonic tip movement
- Scaling and root planing
- Retrograde preparation of root canals
Device Description
The OSSTEMPiezo uses piezoelectric ultrasonic technology to generate mechanical microvibrations for bone cutting and ultrasonic scaling, with minimal trauma to soft tissue. The device is supplied with rer smoothing and blunt insert tips for use in oral surgery, including implantology, periodontal surgery, endodontic surgery and surgical orthodontics.
The device uses piezoeledric ultrasonic technology to generate mechanical microvibrations of insert tips for cutting mineralized structures with minimal trauma to soft tissue and for ultrasonic scaling.
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