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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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DNTK MAX PROTECT DNTL GRD 12
DenTek Oral Care, Inc.
00027701203G
In Commercial Distribution

  • 50047701002778 ()
  • 00047701002773 ()


  • Custom-made mouthguard
DNTK FRSH PROTECT 16CT GRD 12
DenTek Oral Care, Inc.
10047701001759
In Commercial Distribution

  • 10047701001759 ()
  • 00047701001752 ()


  • Custom-made mouthguard
DNTK CMF FIT 2CT DNTL GRD 12
DenTek Oral Care, Inc.
00015101203I2
In Commercial Distribution

  • 40047701001514 ()
  • 00047701001516 ()


  • Custom-made mouthguard
DNTK FRSH PROTECT 6CT GRD 12
DenTek Oral Care, Inc.
10047701001322
In Commercial Distribution

  • 00047701001325 ()
  • 10047701001322 ()


  • Custom-made mouthguard
DNTK FRSH PROTECT 32CT GRD 12
DenTek Oral Care, Inc.
10047701000554
In Commercial Distribution

  • 00047701000557 ()
  • 10047701000554 ()


  • Custom-made mouthguard
DNTK ULTIMATE 1CT DNTL GRD CND 12
DenTek Oral Care, Inc.
10047701000417
In Commercial Distribution

  • 10047701000417 ()
  • 00047701000410 ()


  • Custom-made mouthguard
DNTK ULTIMATE 1CT DNTL GRD 12
DenTek Oral Care, Inc.
10047701000400A
In Commercial Distribution

  • 10047701000400 ()
  • 00047701000403 ()


  • Custom-made mouthguard
TD NIGHTGUARD ADVANCED CND 12
Medtech Products Inc.
79932E
In Commercial Distribution

  • 10042037799325 ()
  • 00042037799328 ()


  • Custom-made mouthguard
TD NGHTGRD ADV 1CT PAD 12
Medtech Products Inc.
79922B
In Commercial Distribution

  • 10042037101432 ()
  • 00042037799229 ()


  • Custom-made mouthguard
SICAT OPTIMOTION
SiCAT GmbH & Co. KG
10501
In Commercial Distribution

  • D776105010 ()
10501

  • Custom-made mouthguard
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