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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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Aeliteflo - 00810111540131

AELITEFLO L/C Comp A1 1.5gm
BISCO INC.
H-671A1
In Commercial Distribution

H-671A1

  • Dental composite resin

TheraCal LC - 00810111540049

TheraCal LC .25g Syringe Pkg
BISCO INC.
H-3302PS
In Commercial Distribution

H-3302PS

  • Dental composite resin

TheraCal LC - 00810111540032

TheraCal LC 0.25g Single Syringe SMPL
BISCO INC.
H-3302S
In Commercial Distribution

H-3302S

  • Dental composite resin

TheraCal LC - 00810111540025

TheraCal LC 4 - 1g Syringe Pkg
BISCO INC.
H-33014P
In Commercial Distribution

H-33014P

  • Dental composite resin

TheraCal LC - 00810111540018

TheraCal LC 1g Syringe Pkg
BISCO INC.
H-3301P
In Commercial Distribution

H-3301P

  • Dental composite resin

TheraCal LC - 00810111540001

TheraCal LC 1g Syringe
BISCO INC.
H-3301
In Commercial Distribution

H-3301

  • Dental composite resin

Quantium - 00810111543316

Quantium Syringe Kit w/ Select HV Etch w/o BAC
BISCO INC.
H-12000K
In Commercial Distribution

  • 00810111543316 ()
H-12000K

  • Dental composite resin

Quantium - 00810111543309

Quantium Syringe Kit w/ Select HV Etch w/BAC
BISCO INC.
H-10000K
In Commercial Distribution

  • 00810111543309 ()
H-10000K

  • Dental composite resin

Quantium - 00810111543293

Quantium Unit Dose Kit w/ Select HV Etch w/o BAC
BISCO INC.
H-10120K
In Commercial Distribution

  • 00810111543293 ()
H-10120K

  • Dental composite resin

Quantium - 00810111543286

Quantium Unit-Dose Kit w/ Select HV Etch w/BAC
BISCO INC.
H-10100K
In Commercial Distribution

  • 00810111543286 ()
H-10100K

  • Dental composite resin
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