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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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Dental aspirator tips
Premium Plus International Limited
009V
In Commercial Distribution

  • D838009V8 ()
  • D838009V6 ()
  • D838009V4 ()
  • D838009V0 ()


  • Dental suction system cannula, single-use
Dental aspirator tips
Premium Plus International Limited
008V
In Commercial Distribution

  • D838008V8 ()
  • D838008V6 ()
  • D838008V4 ()
  • D838008V0 ()


  • Dental suction system cannula, single-use
SUCTION TUBES
Premium Plus International Limited
006P-ASS
In Commercial Distribution

  • D838006PASS8 ()
  • D838006PASS6 ()
  • D838006PASS4 ()
  • D838006PASS0 ()


  • Dental suction system cannula, reusable
Dental oral evacuators
Premium Plus International Limited
005L-ASS
In Commercial Distribution

  • D838005LASS8 ()
  • D838005LASS6 ()
  • D838005LASS4 ()
  • D838005LASS0 ()


  • Dental suction system cannula, reusable
dappen dish
Premium Plus International Limited
004B-WHITE
In Commercial Distribution

  • D838004WHITE8 ()
  • D838004WHITE6 ()
  • D838004WHITE2 ()
  • D838004WHITE0 ()


  • Dappen dish, single-use
dappen dish
Premium Plus International Limited
004B-LAV
In Commercial Distribution

  • D838004LAV8 ()
  • D838004LAV6 ()
  • D838004LAV2 ()
  • D838004LAV0 ()


  • Dappen dish, single-use
Orthodontic appliance system, progressive FDA PT: HJDC
Digital Orthodontic Care
Aligners
In Commercial Distribution

  • D918SCA2 ()
  • D918SCA1 ()
  • D918SCA0 ()


  • Orthodontic progressive aligner
MRI ECG Electrode 110mm x 110mm
MIPM Mammendorfer Institut für Physik und Medizin GmbH
large
In Commercial Distribution

  • EMIP53002030 ()
  • EMIP53002031 ()
  • EMIP53002032 ()
5300203

  • Electrocardiographic electrode, single-use
MRI ECG Electrode 70mm x 70mm
MIPM Mammendorfer Institut für Physik und Medizin GmbH
small
In Commercial Distribution

  • EMIP53002020 ()
  • EMIP53002021 ()
  • EMIP53002022 ()
5300202

  • Electrocardiographic electrode, single-use
The Etchmaster system is intended for use for polishing, roughening and/or etching of tooth surfaces, enamel, dentin, and dental restorations for adhesive restorative procedures. This is the Etchmaster Regular Small Tips
RELIANCE ORTHODONTIC PRODUCTS INC
EMTRS
In Commercial Distribution

  • D798EMTRS1 ()
  • D798EMTRS0 ()
  • D798EMTRS2 ()
  • D798EMTRS3 ()
EMTRS

  • Dental abrasive air jet system
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