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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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EXPM MBT 022 U 5-5 HK 3,4,5
Gc Orthodontics America Inc.
12-2C05-0020
In Commercial Distribution

  • D788122C0500201 ()
12-2C05-0020

  • Orthodontic bracket, ceramic
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
EXC MBT 022 U/L 5-5 HK3
Gc Orthodontics America Inc.
11-2CC3-0020
In Commercial Distribution

  • D788112CC300201 ()
11-2CC3-0020

  • Orthodontic bracket, ceramic
CHIC/LMI ROTH 018 U/L5-5 HK345
Gc Orthodontics America Inc.
14/31-1CC5-0010
In Commercial Distribution

  • D78814311CC500101 ()
14/31-1CC5-0010

  • Orthodontic bracket, ceramic
  • Orthodontic bracket, metal
Chic Roth 022 U 5-5 HK 345
Gc Orthodontics America Inc.
14-2C05-S010
In Commercial Distribution

  • D788142C05S0101 ()
14-2C05-S010

  • Orthodontic bracket, ceramic
CHIC ROTH U 2-2 MBT HK 345
Gc Orthodontics America Inc.
14-2C05-10020
In Commercial Distribution

  • D788142C05100201 ()
14-2C05-10020

  • Orthodontic bracket, ceramic
CHIC MBT 022 U 6-6 HK 345
Gc Orthodontics America Inc.
14-2B05-9308
In Commercial Distribution

  • D788142B0593081 ()
14-2B05-9308

  • Orthodontic bracket, ceramic
EXC ROTH 022 U 7-7 HK 345
Gc Orthodontics America Inc.
11-2A05-3260
In Commercial Distribution

  • D788112A0532601 ()
11-2A05-3260

  • Orthodontic bracket, ceramic
UCLA MOD. HERBST-ONE SEGMENT U OR L
SELANE PRODUCTS, INC.
63251S
In Commercial Distribution

  • D85463251S1 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
TEW T 018/U&L4-5 MED OW
DENTSPLY SIRONA ORTHODONTICS INC.
05-351-21
Not in Commercial Distribution

  • D80705351211 ()
  • D80705351210 ()
05-351-21

  • Orthodontic bracket, metal
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