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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Piezosurgery Touch is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts, intended for: · 1) Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic, and surgical endodontic procedures; 2) Scaling applications, including: • Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits; • Perlodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket Irrigation and cleaning; • Endodontics: All treatments for root canal reaming, irrigation, revision, filling, gutta-percha condensation and retrograde preparation; • Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.
MECTRON SPA
PIEZOSURGERY TOUCH
In Commercial Distribution

  • E322040000860 ()
04000086

  • Ultrasonic dental scaling/debridement system
  • Dental ultrasonic surgical system
The Compact Piezo P2K device is an ultrasonic scaler intended for use, with the appropriate associated insert tips, in the following dental applications: Scaling: All general procedures for removal of supragingival and interdental calculus/plaque deposits. Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning. Endodontics: All treatments for root canal reaming, irrigation, revision, filling, gutta-percha condensation and Retrograde preparation. Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.
MECTRON SPA
COMPACT-PIEZO P2K
In Commercial Distribution

  • E322040000790 ()
04000079

  • Ultrasonic dental scaling/debridement system
No Description
BLUO ELECTRONICS SRL
9319001700
In Commercial Distribution

  • E3159319001700 ()


  • Stationary intraoral dental x-ray system, digital
No Description
BLUO ELECTRONICS SRL
8468600008
In Commercial Distribution

  • E3158468600008 ()


  • Stationary panoramic dental x-ray system, digital
No Description
BLUO ELECTRONICS SRL
8468600007
In Commercial Distribution

  • E3158468600007 ()


  • Stationary panoramic dental x-ray system, digital
No Description
BLUO ELECTRONICS SRL
8468600002
In Commercial Distribution

  • E3158468600002 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
No Description
BLUO ELECTRONICS SRL
8468600000
In Commercial Distribution

  • E3158468600000 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
No Description
Humeca B.V.
4.D42STS
In Commercial Distribution

  • 08717903490402 ()
  • 08717903490358 ()
4.D42STS

  • Dermatome handpiece, electrically-powered
No Description
ECHOSENS
FibroScan 230
In Commercial Distribution

  • 03662264001222 ()


  • Hepatic ultrasound elastography system
No Description
ECHOSENS
FibroScan 430 MINI+
In Commercial Distribution



  • Hepatic ultrasound elastography system
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