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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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COE® - D6582503011

COE® SPACER TRAYS #30D Upper L, Lower R Perforated-Partial
Gc America Inc.
250301
In Commercial Distribution

  • D6582503062 ()
  • D6582503011 ()
  • D6582530124 ()
  • D6582503010 ()
250301

  • Dental impression tray, single-use

COE® - D6582502211

COE® SPACER TRAYS #22D Small Lower Perforated
Gc America Inc.
250221
In Commercial Distribution

  • D6582502262 ()
  • D6582502211 ()
  • D6582522124 ()
  • D6582502210 ()
250221

  • Dental impression tray, single-use

COE® - D6582502111

COE® SPACER TRAYS #21D Medium Lower Perforated
Gc America Inc.
250211
In Commercial Distribution

  • D6582502162 ()
  • D6582502111 ()
  • D6582521124 ()
  • D6582502110 ()
250211

  • Dental impression tray, single-use

COE® - D6582502011

COE® SPACER TRAYS #20D Large Lower Perforated
Gc America Inc.
250201
In Commercial Distribution

  • D6582520124 ()
  • D6582502062 ()
  • D6582502011 ()
  • D6582502010 ()
250201

  • Dental impression tray, single-use

COE® - D6582500961

COE® SPACER TRAYS Perforated Assorted Package
Gc America Inc.
250096
In Commercial Distribution

  • D6582500962 ()
  • D6582500961 ()
  • D6582501124 ()
  • D6582500960 ()
250096

  • Dental impression tray, single-use

COE® - D6582500711

COE® SPACER TRAYS #7D Small Upper Perforated
Gc America Inc.
250071
In Commercial Distribution

  • D6582500762 ()
  • D6582500711 ()
  • D6582507124 ()
  • D6582500710 ()
250071

  • Dental impression tray, single-use

COE® - D6582500411

COE® SPACER TRAYS #4D Medium Upper Perforated
Gc America Inc.
250041
In Commercial Distribution

  • D6582500462 ()
  • D6582500411 ()
  • D6582504124 ()
  • D6582500410 ()
250041

  • Dental impression tray, single-use

COE® - D6582500111

COE® SPACER TRAYS #1D Large Upper Perforated
Gc America Inc.
250011
In Commercial Distribution

  • D6582500124 ()
  • D6582500162 ()
  • D6582500111 ()
  • D6582500110 ()
250011

  • Dental impression tray, single-use

ScanX Swift Digital Imaging System - D678G80100

A device that scans photostimulable phosphor plates that have been exposed in the place of dental x-ray film and allows those images to be displayed on a CRT and stored for later recovery in a computer memory. It will be used by dentists and authorized dental auxiliary personnel for this purpose. This kit contains an installation disc, USB cable and power supply, PSPs, barrier envelopes, barrier film rolls, PSP wipes, and a scanner cleaning sheet.
AIR TECHNIQUES, INC.
G8010
In Commercial Distribution

  • D678G80001 ()
  • D678G80100 ()
  • D678G80101 ()

  • Weight: 14.5 Pound
  • Outer Diameter: 9.6 Inch
  • Height: 9.2 Inch
  • Width: 8.9 Inch


  • Radiography digital imaging scanner

CamX Spectra Caries Detection Aid - D678G41000

The CamX Spectra Fluorescence Caries Detection Aid System aids in the diagnosis of caries. It consists of a toothbrush-sized handpiece for examining the condition of a tooth, an umbilical cord connecting the handpiece to a computer and imaging software.
AIR TECHNIQUES, INC.
G4100
In Commercial Distribution

  • D678G41000 ()
  • D678G40001 ()
  • DG78G41001 ()


  • Dental caries detector, optical induced fluorescence
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