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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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U SU DMND CLDR 878 012 F
COLTENE/WHALEDENT INC
XU878F012
Not in Commercial Distribution

  • D661XU878F0121 ()
  • D661XU878F0120 ()


  • Carbide dental bur, reusable
U SU DMND FLAME 859 014 C
COLTENE/WHALEDENT INC
XU859C014
In Commercial Distribution

  • D661XU859C0141 ()
  • D661XU859C0140 ()


  • Carbide dental bur, reusable
SS GHT FORM C 16x22 U RECTANGULAR
Gc Orthodontics America Inc.
78-C5U0-1622
In Commercial Distribution

  • E53578C5U016220 ()
  • E53578C5U016221 ()
78-C5U0-1622

  • Orthodontic archwire
NITI FORM A 18X18 U PK10 DIMPLED
Gc Orthodontics America Inc.
77-A0UD-1818
In Commercial Distribution

  • E53577A0UD18180 ()
  • E53577A0UD18181 ()
77-A0UD-1818

  • Orthodontic archwire
SW EDGE 022/U&L4&5 WD
Gc Orthodontics America Inc.
26-2740-0059
In Commercial Distribution

  • D78826274000591 ()
  • D78826274000590 ()
26-2740-0059

  • Orthodontic bracket, metal
LEW T 022/U&L4&5 NAR
Gc Orthodontics America Inc.
26-2740-0050
In Commercial Distribution

  • D78826274000501 ()
  • D78826274000500 ()
26-2740-0050

  • Orthodontic bracket, metal
EXM MBT 022 U/L 6-6 3HK
Gc Orthodontics America Inc.
20-2BB3-0020
In Commercial Distribution

  • D788202BB300201 ()
20-2BB3-0020

  • Orthodontic bracket, metal
EXP ROTH 022 U 6-6 HK 3,4
Gc Orthodontics America Inc.
20-2B04-8439
In Commercial Distribution

  • D788202B0484390 ()
  • D788202B0484391 ()
20-2B04-8439

  • Orthodontic bracket, metal
EXM MBT 018 U/L 5-5 HK3,4
Gc Orthodontics America Inc.
20-1CC4-0020
In Commercial Distribution

  • D788201CC400201 ()
20-1CC4-0020

  • Orthodontic bracket, metal
EXC ROTH 022 U 4-4 HK 34
Gc Orthodontics America Inc.
11-2D04-0010
In Commercial Distribution

  • D788112D0400101 ()
11-2D04-0010

  • Orthodontic bracket, ceramic
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