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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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Hygenic - D661H003480

5 lb Lab Pack Perm Resin - Heavy Veined
COLTENE/WHALEDENT INC
H00348
In Commercial Distribution

  • D661H003480 ()


  • Resin artificial teeth

Hygenic - D661H003430

5 lb Lab Pack Perm Resin - Special Veined
COLTENE/WHALEDENT INC
H00343
In Commercial Distribution

  • D661H003430 ()


  • Resin artificial teeth

Hygenic - D661H002890

5 lb Lab Pack Hyg Repair Resin - Veined
COLTENE/WHALEDENT INC
H00289
In Commercial Distribution

  • D661H002890 ()


  • Resin artificial teeth

Steri-Endo Guard Engine - D68550Z452U0

Organizes 11 engines and 5 hand files/reamers.
ZIRC DENTAL PRODUCTS, INC.
U-Copper
In Commercial Distribution

  • D68550Z452U0 ()
50Z452U

  • Sterilization packaging, reusable

Steri-Endo Guard Engine - D68550Z452T0

Organizes 11 engines and 5 hand files/reamers.
ZIRC DENTAL PRODUCTS, INC.
T-Midnight Blue
In Commercial Distribution

  • D68550Z452T0 ()
50Z452T

  • Sterilization packaging, reusable

Steri-Endo Guard Engine - D68550Z452S0

Organizes 11 engine and 5 hand files/reamers.
ZIRC DENTAL PRODUCTS, INC.
S-Neon Pink
In Commercial Distribution

  • D68550Z452S0 ()
50Z452S

  • Sterilization packaging, reusable

Steri-Endo Guard Engine - D68550Z452R0

Organizes 11 engines and 5 hand files/reamers.
ZIRC DENTAL PRODUCTS, INC.
R-Neon Purple
In Commercial Distribution

  • D68550Z452R0 ()
50Z452R

  • Sterilization packaging, reusable

Steri-Endo Guard Engine - D68550Z452Q0

Organizes 11 engines and 5 hand files/reamers.
ZIRC DENTAL PRODUCTS, INC.
Q-Neon Orange
In Commercial Distribution

  • D68550Z452Q0 ()
50Z452Q

  • Sterilization packaging, reusable

Steri-Endo Guard Engine - D68550Z452P0

Organizes 11 engines and 5 hand files/reamers.
ZIRC DENTAL PRODUCTS, INC.
P-Neon Green
In Commercial Distribution

  • D68550Z452P0 ()
50Z452P

  • Sterilization packaging, reusable

Steri-Endo Guard Engine - D68550Z452O0

Organizes 8 engine and 5 hand files/reamers.
ZIRC DENTAL PRODUCTS, INC.
O-Neon Yellow
In Commercial Distribution

  • D68550Z452O0 ()
50Z452O

  • Sterilization packaging, reusable
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