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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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HDI 1000 is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. Forpatient comfort, theergonomic design is based on human intraoral anatomy
Rayence Co., Ltd.
HDI1000
In Commercial Distribution

  • 08800018600108 ()
1.5

  • Dental digital imaging sensor, intraoral
EzSensor Pi is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. For patient comfort, the ergonomic design is based on human intraoral anatomy
Rayence Co., Ltd.
EzSensor Pi
In Commercial Distribution

  • 08800018600092 ()
2.0

  • Dental digital imaging sensor, intraoral
EzSensor Pi is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. For patient comfort, the ergonomic design is based on human intraoral anatomy
Rayence Co., Ltd.
EzSensor Pi
In Commercial Distribution

  • 08800018600085 ()
1.5

  • Dental digital imaging sensor, intraoral
EzSensor P is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. For patient comfort, the ergonomic design is based on human intraoral anatomy.
Rayence Co., Ltd.
EzSensor P
In Commercial Distribution

  • 08800018600078 ()
2.0

  • Dental digital imaging sensor, intraoral
EzSensor P is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. For patient comfort, the ergonomic design is based on human intraoral anatomy.
Rayence Co., Ltd.
EzSensor P
In Commercial Distribution

  • 08800018600061 ()
1.5

  • Dental digital imaging sensor, intraoral
EzSensor is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. For patient comfort, the ergonomic design is based on human intraoral anatomy
Rayence Co., Ltd.
EzSensor i 2.0
In Commercial Distribution

  • 08800018600054 ()


  • Dental digital imaging sensor, intraoral
EzSensor is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. For patient comfort, the ergonomic design is based on human intraoral anatomy.
Rayence Co., Ltd.
EzSensor i 1.5
In Commercial Distribution

  • 08800018600047 ()


  • Dental digital imaging sensor, intraoral
The subject device, AROMA GRAND is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). It utilizes a semiconductor diode as a laser source (808nm). The laser power is delivered to the treatment area via a laser hand-piece.
Daeju Medi Tech Engineering
1.0
In Commercial Distribution

  • 08800017500126 ()


  • Dermatological diode laser system
Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064 nm) Tattoo Removal: Dark ink (blue and black) (1064 nm) Tattoo Removal: light ink (red, sky blue, green) (532 nm) telangiectasias (532 nm) spider nevi (532 nm) solar lentiginos, senile lentiginos, becker's nevi, freckles (532 nm) nevus of ota (1064 nm)
Daeju Medi Tech Engineering
1.0
In Commercial Distribution

  • 08800017500102 ()
DJMD0004

  • Multi-modality skin surface treatment system generator
EzSensor is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. For patient comfort, the ergonomic design is based on human intraoral anatomy.
Rayence Co., Ltd.
EzSensor i 1.0
In Commercial Distribution

  • 08800018600030 ()


  • Dental digital imaging sensor, intraoral
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