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510(k) Data Aggregation
K Number
K083284Device Name
PIEZOSURGERY MEDICAL
Manufacturer
PIEZOSURGERY SRL
Date Cleared
2009-04-08
(152 days)
Product Code
JDX, DZI, ERL, HBE, HWE
Regulation Number
888.4580Why did this record match?
Applicant Name (Manufacturer) :
PIEZOSURGERY SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Piezosurgery MEDICAL is an ultrasonic surgical system consisting of handpieces and associated tips for cutting bone, osteotomy, osteoplasty and drilling in variety of surgical procedures, including but not limited to otolaryngological, oral/maxillofacial, hand, foot, neurosurgical, spine, and plastic/reconstructive surgery. It may also be used with endoscopic visual assistance to perform the above listed procedures.
Device Description
The Piezosurgery® Medical device is an ultrasonic surgical system consisting of a central console with two integral peristaltic irrigation pumps, and two detachable handpieces. Each handpiece is connected to the console electrically, and each is also connected to one of the irrigation pumps via an irrigation tubing kit. The handpieces contain the ultrasonic transducers. A separate electricallyoperated footswitch is provided with the device, which also attaches to the central console. The irrigation tubing kits and insert tips are supplied sterile and are intended for single-use. A range of optionally available handpiece tips provides the surgeon with a wide variety of options for drilling, cutting and sawing.
The console has a touch-screen display and contains general control system circuits and two ultrasonic generators which drive the handpiece functions. The irrigation tubing kit is fed with physiological saline solution during the surgical procedure from saline bags (not supplied) which hang from drip stands that attach to the rear of the central console.
The user may activate either of the two handpieces by the selection from the LCD touch-screen and by pressing the footswitch.
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K Number
K052518Device Name
PIEZOSURGERY
Manufacturer
PIEZOSURGERY SRL
Date Cleared
2005-11-16
(63 days)
Product Code
ELC
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
PIEZOSURGERY SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Piezosurgery® device is intended for use in the following dental applications:
- Bone cutting for use in oral surgery (K043408) -
- 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 Piezosurgery® device 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 sharp, smoothing and blunt insert tips for use in oral surgery, including implantology, periodontal surgery, endodontic surgery and surgical orthodontics.
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K Number
K043408Device Name
PIEZOSURGERY DEVICE
Manufacturer
PIEZOSURGERY SRL
Date Cleared
2005-06-08
(180 days)
Product Code
DZI
Regulation Number
872.4120Why did this record match?
Applicant Name (Manufacturer) :
PIEZOSURGERY SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Piezosurgery device is a bone cutting instrument intended for use in oral surgery.
Device Description
The Piezosurgery® device uses piezoelectric ultrasonic technology to generate mechanical The riezdsurgery done cutting, with minimal trauma to soft tissue. The device is supplied mith sharp, smoothing and blunt insert tips for use in oral surgery, including implantology, periodontal surgery and surgical orthodontics.
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