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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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EXP L SL Roth 018 U/L 6-6
Gc Orthodontics America Inc.
16-1BB0-0010
In Commercial Distribution

  • D788161BB000101 ()
16-1BB0-0010

  • Orthodontic bracket, metal
EXL 018/U&L4&5 UNIV 10T 0A
Gc Orthodontics America Inc.
16-1740-0010
In Commercial Distribution

  • D78816174000101 ()
  • D78816174000100 ()
16-1740-0010

  • Orthodontic bracket, metal
Chic MBT 022 U/L 505 HK 345
Gc Orthodontics America Inc.
14-2CC5-S020
In Commercial Distribution

  • D788142CC5S0201 ()
14-2CC5-S020

  • Orthodontic bracket, ceramic
Chic Roth 022 U/L 5-5 HK 34
Gc Orthodontics America Inc.
14-2CC4-S010
In Commercial Distribution

  • D788142CC4S0101 ()
14-2CC4-S010

  • Orthodontic bracket, ceramic
CHIC MBT 022 U/L 7-7 HK 345
Gc Orthodontics America Inc.
14-2AA5-0168
In Commercial Distribution

  • D788142AA501680 ()
14-2AA5-0168

  • Orthodontic bracket, ceramic
Chic Roth 018 U/L 5-5 HK 345
Gc Orthodontics America Inc.
14-1CC5-S010
In Commercial Distribution

  • D788141CC5S0101 ()
14-1CC5-S010

  • Orthodontic bracket, ceramic
Chic Roth 018 U/L 5-5 HK 34
Gc Orthodontics America Inc.
14-1CC4-S010
In Commercial Distribution

  • D788141CC4S0101 ()
14-1CC4-S010

  • Orthodontic bracket, ceramic
Ceraket .022 Kit U/L 5x5 Roth HKS
HENRY SCHEIN, INC.
1125959
In Commercial Distribution

  • H65811259599 ()
  • H65811259591 ()
1125959

  • Orthodontic bracket, ceramic
TEW T 022/U&L4-5 MED OW 7T
DENTSPLY SIRONA ORTHODONTICS INC.
05-352-21
Not in Commercial Distribution

  • D80705352211 ()
  • D80705352210 ()
05-352-21

  • Orthodontic bracket, metal
TEW T 018/U&L3 WD 7T STD
DENTSPLY SIRONA ORTHODONTICS INC.
38-331-07
Not in Commercial Distribution

  • D80738331071 ()
  • D80738331070 ()
38-331-07

  • Orthodontic bracket, metal
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