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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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SCALEX - 00858466005141

Ultrasonic Scaler
DENTAMERICA, INC.
890
In Commercial Distribution

  • 00858466005141 ()


  • Dental delivery system instrument unit, electric

SCALEX - 00858466005127

Ultrasonic Scaler
DENTAMERICA, INC.
880P
In Commercial Distribution

  • 00858466005127 ()


  • Dental delivery system instrument unit, electric

SCALEX - 00858466005103

Ultrasonic Scaler
DENTAMERICA, INC.
800
In Commercial Distribution

  • 00858466005103 ()


  • Dental delivery system instrument unit, electric

SCALEX - 00858466005134

Ultrasonic Scaler
DENTAMERICA, INC.
850
In Commercial Distribution

  • 00858466005134 ()


  • Dental delivery system instrument unit, electric

SCALEX - 00858466005110

Ultrasonic Scaler
DENTAMERICA, INC.
830
In Commercial Distribution

  • 00858466005110 ()


  • Dental delivery system instrument unit, electric

Posterior CleanFlow Procedure Instrument with Matrix - 00858395006783

CleanFlow Device used with the GentleWave System to treat root canals (Posterior teeth).
SONENDO, INC.
FG-013-00004
In Commercial Distribution

  • 00858395006783 ()
GW-PST-PI01

  • Dental delivery system instrument unit, electric

GentleWave G4 Console - 00858395006776

GentleWave G4 Console
SONENDO, INC.
FG-012-00005
In Commercial Distribution

  • 00858395006776 ()


  • Dental delivery system instrument unit, electric

GentleWave G4 Support Arm - 00858395006769

No Description
SONENDO, INC.
FG-012-00002
In Commercial Distribution

  • 00858395006769 ()
GW-ARM-0001

  • Dental delivery system instrument unit, electric

Posterior Cleanflow Matrices - 00858395006738

Posterior Cleanflow Matrices (10 Pack)
SONENDO, INC.
FG-013-00007
In Commercial Distribution

  • 00858395006745 ()
  • 00858395006738 ()
GW-PST-OMTX

  • Dental delivery system instrument unit, electric

Premolar CrossFire Procedure Instrument with Matrix - 00858395006684

The Premolar CrossFire Procedure Instrument with Matrix, when used with the Sonendo GentleWave Console, is intended to be used on premolar teeth indicated for root canal therapy. The device is a hand held dental instrument which contains both fluid delivery and fluid recovery pathways within a polymer casing. The exterior shape of the device is designed to fit the curvature of the human hand and allow ease of application to the treatment site.
SONENDO, INC.
FG-014-00003
In Commercial Distribution

  • 00858395006684 ()
GW-PRE-XF01

  • Dental delivery system instrument unit, electric
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