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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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CC/ Approx. Dentine AD-1 light yellow
KLEMA Dentalprodukte GmbH
001568
In Commercial Distribution

  • ECWG0015681 ()
001568

  • Dental appliance fabrication material, ceramic
CC/ Make In MI-65 gold 15g
KLEMA Dentalprodukte GmbH
001565
In Commercial Distribution

  • ECWG0015651 ()
001565

  • Dental appliance fabrication material, ceramic
CC/ Make In MI-64 flamingo 15g
KLEMA Dentalprodukte GmbH
001564
In Commercial Distribution

  • ECWG0015641 ()
001564

  • Dental appliance fabrication material, ceramic
CC/ Make In MI-61 ivory 15g
KLEMA Dentalprodukte GmbH
001561
In Commercial Distribution

  • ECWG0015611 ()
001561

  • Dental appliance fabrication material, ceramic
CC/ Opaque Dentine OD-44 (cuba) 15g
KLEMA Dentalprodukte GmbH
001544
In Commercial Distribution

  • ECWG0015441 ()
001544

  • Dental appliance fabrication material, ceramic
CC/ Shoulder SP-26 yellow grey 15g
KLEMA Dentalprodukte GmbH
001526
In Commercial Distribution

  • ECWG0015261 ()
001526

  • Dental appliance fabrication material, ceramic
CC/ Effect Enamel SI-05 medium orange
KLEMA Dentalprodukte GmbH
000569
In Commercial Distribution

  • ECWG0005691 ()
000569

  • Dental appliance fabrication material, ceramic
CC/ Effect Enamel SI-03 heavy yellow
KLEMA Dentalprodukte GmbH
000567
In Commercial Distribution

  • ECWG0005671 ()
000567

  • Dental appliance fabrication material, ceramic
CC/ Effect Enamel SI-01 light yellow
KLEMA Dentalprodukte GmbH
000565
In Commercial Distribution

  • ECWG0005651 ()
000565

  • Dental appliance fabrication material, ceramic
CC/ Creapast IO gold yellow 3g
KLEMA Dentalprodukte GmbH
000320
In Commercial Distribution

  • ECWG0003201 ()
000320

  • Dental appliance fabrication material, ceramic
CC/ Pearl Enamel PS-1 blue/white
KLEMA Dentalprodukte GmbH
000282
In Commercial Distribution

  • ECWG0002821 ()
000282

  • Dental appliance fabrication material, ceramic
CC/ Bleach Kit (incl. shade guide)
KLEMA Dentalprodukte GmbH
000250
In Commercial Distribution

  • ECWG0002501 ()
000250

  • Dental appliance fabrication material, ceramic
PHILIPS CC TABLE PAD CONTOUR FOAM
AADCO MEDICAL, INC.
TP-910
In Commercial Distribution

  • 00840348511055 ()
TP-910

  • Freestanding patient positioner, reusable
Transfer Screw 2 Parts - Short - CC
FAICO MEDICAL LLC
AVR00SHOSN00C
Not in Commercial Distribution

  • 00840192702128 ()


  • Dental implant system
Transfer Screw 2 Parts - Long - CC
FAICO MEDICAL LLC
AVR00LNGSN00C
Not in Commercial Distribution

  • 00840192702111 ()


  • Dental implant system
Screw Cap h.4 mm. - CC
FAICO MEDICAL LLC
AVT000400000C
Not in Commercial Distribution

  • 00840192701411 ()


  • Dental implant system
Screw Cap h.2 mm. - CC
FAICO MEDICAL LLC
AVT000200000C
Not in Commercial Distribution

  • 00840192701404 ()


  • Dental implant system
Ratchet Extraction Key (OUT) - Short - CC
FAICO MEDICAL LLC
AST00SHOEMCRC
Not in Commercial Distribution

  • 00840192716446 ()


  • Dental implant system
Ratchet Activation Key (IN) - Short - CC
FAICO MEDICAL LLC
AST00SHOAMCRC
Not in Commercial Distribution

  • 00840192716439 ()


  • Dental implant system
ID II LIF Inserter Sleeve, C-C
ALPHATEC SPINE, INC.
801-140-50
In Commercial Distribution

  • 00190376635439 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
AlloFuse® DBM Gel, 5 cc
ALLOSOURCE
90138005
In Commercial Distribution

  • M536901380051 ()

  • 5 cc
90138005

  • Bone matrix implant, human-derived
AlloFuse® DBM Gel, 1 cc
ALLOSOURCE
90138001
In Commercial Distribution

  • M536901380011 ()

  • 1 cc
90138001

  • Bone matrix implant, human-derived
AlloFuse® DBM Putty, 10 cc
ALLOSOURCE
90038010
In Commercial Distribution

  • M536900380101 ()

  • 10 cc
90038010

  • Bone matrix implant, human-derived
AlloFuse® DBM Putty, 5 cc
ALLOSOURCE
90038005
In Commercial Distribution

  • M536900380051 ()

  • 5 cc
90038005

  • Bone matrix implant, human-derived
AlloFuse® DBM Putty, 2.5 cc
ALLOSOURCE
90038002
In Commercial Distribution

  • M536900380021 ()

  • 2.5 cc
90038002

  • Bone matrix implant, human-derived
AlloFuse® DBM Putty, 1 cc
ALLOSOURCE
90038001
In Commercial Distribution

  • M536900380011 ()

  • 1 cc
90038001

  • Bone matrix implant, human-derived
Slim Sigma TLIF CC Blade 70mm
ALPHATEC SPINE, INC.
CI-11840-70
In Commercial Distribution

  • 00840180539538 ()


  • Surgical retraction system, reusable
Slim Sigma TLIF CC Blade 90mm
ALPHATEC SPINE, INC.
CI-11840-90
In Commercial Distribution

  • 00840180539545 ()


  • Surgical retraction system, reusable
CC DRILL GUIDE - THREAD IN, 24MM
ALPHATEC SPINE, INC.
CI-11444-24
In Commercial Distribution

  • 00840180523773 ()


  • Surgical drill guide, reusable
CC DRILL GUIDE - THREAD IN, 22MM
ALPHATEC SPINE, INC.
CI-11444-22
In Commercial Distribution

  • 00840180523766 ()


  • Surgical drill guide, reusable
CC DRILL GUIDE - THREAD IN, 20MM
ALPHATEC SPINE, INC.
CI-11444-20
In Commercial Distribution

  • 00840180523759 ()


  • Surgical drill guide, reusable
CC DRILL GUIDE - THREAD IN, 18MM
ALPHATEC SPINE, INC.
CI-11444-18
In Commercial Distribution

  • 00840180523742 ()


  • Surgical drill guide, reusable
Scanbody Direct Nano Short 3Pod - CC
FAICO MEDICAL LLC
ASBNS00000PPC
Not in Commercial Distribution

  • 00840192718259 ()


  • Dental implant system
REAMERS CC 25MM NO 45 PK6
DARBY DENTAL SUPPLY, LLC
9512827
In Commercial Distribution

  • 00889813009802 ()
  • 00889813009796 ()
9512827

  • Endodontic reamer
REAMERS CC 25MM NO 50 PK6
DARBY DENTAL SUPPLY, LLC
9512829
In Commercial Distribution

  • 00889813007334 ()
  • 00889813007327 ()
9512829

  • Endodontic reamer
REAMERS CC 25MM NO 40 PK6
DARBY DENTAL SUPPLY, LLC
9512825
In Commercial Distribution

  • 00889813007310 ()
  • 00889813007303 ()
9512825

  • Endodontic reamer
Screw, Poly, MIS, CC Cann, 5.5x65
Surgalign Spine Technologies, Inc.
150152-55065
In Commercial Distribution

  • 00840311203727 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 5.5x60
Xtant Medical Holdings, Inc.
150152-55060
In Commercial Distribution

  • 00840311203710 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 5.5x55
Xtant Medical Holdings, Inc.
150152-55055
In Commercial Distribution

  • 00840311203703 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 5.5x50
Xtant Medical Holdings, Inc.
150152-55050
In Commercial Distribution

  • 00840311203697 ()


  • Bone-screw internal spinal fixation system, non-sterile
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