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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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ALPEN X1 FLAME, MEDIUM
COLTENE/WHALEDENT INC
X862M012
Not in Commercial Distribution

  • D661X862M0121 ()
  • D661X862M0120 ()


  • Carbide dental bur, reusable
ALPEN X1 FLAME, MEDIUM
COLTENE/WHALEDENT INC
X862M010
Not in Commercial Distribution

  • D661X862M0101 ()
  • D661X862M0100 ()


  • Carbide dental bur, reusable
ALPEN X1 FLAME, FINE
COLTENE/WHALEDENT INC
X862LF018
Not in Commercial Distribution

  • D661X862LF0181 ()
  • D661X862LF0180 ()


  • Carbide dental bur, reusable
ALPEN X1 FLAME, COARSE
COLTENE/WHALEDENT INC
X862LC018
Not in Commercial Distribution

  • D661X862LC0181 ()
  • D661X862LC0180 ()


  • Carbide dental bur, reusable
ALPEN X1 FLAME, FINE
COLTENE/WHALEDENT INC
X862F016
In Commercial Distribution

  • D661X862F0161 ()
  • D661X862F0160 ()


  • Carbide dental bur, reusable
ALPEN X1 FLAME, FINE
COLTENE/WHALEDENT INC
X862F012
In Commercial Distribution

  • D661X862F0121 ()
  • D661X862F0120 ()


  • Carbide dental bur, reusable
ALPEN X1 FLAME, FINE
COLTENE/WHALEDENT INC
X862F010
In Commercial Distribution

  • D661X862F0101 ()
  • D661X862F0100 ()


  • Carbide dental bur, reusable
FLAME EXTRA FINE
COLTENE/WHALEDENT INC
X862EF016
In Commercial Distribution

  • D661X862EF0161 ()
  • D661X862EF0160 ()


  • Carbide dental bur, reusable
FLAME EXTRA FINE
COLTENE/WHALEDENT INC
X862EF012
In Commercial Distribution

  • D661X862EF0121 ()
  • D661X862EF0120 ()


  • Carbide dental bur, reusable
ALPEN X1 FLAME, COARSE
COLTENE/WHALEDENT INC
X862C016
In Commercial Distribution

  • D661X862C0161 ()
  • D661X862C0160 ()


  • Carbide dental bur, reusable
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