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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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LEGACY ROTH 022 U/L 5-5 HK 345
Gc Orthodontics America Inc.
28/27-2CC5-X793
In Commercial Distribution

  • D78828272CC5X7931 ()
28/27-2CC5-X793

  • Orthodontic bracket, metal
TPH®3 flow Liquid Micro Hybrid Compula® Tip Introductory Kit
DENTSPLY INTERNATIONAL INC.
642715
Not in Commercial Distribution

  • D0026427151 ()

  • Total Volume: 0.125 Milliliter
  • 20 Compula® Tips-5 each shade A1, A2, A3, A3.5 (0.25g each), 20 Adhesive Unit Doses, 1 Syringe Tooth Cond Gel, 1 Compules® Tips Gun, 1 Unit Dose Holder, 25 App Needles, 50 App Tips
  • Weight: 0.25 Gram
642715

  • Dental composite resin
Spacerhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=71318#
UNIFIED SPINE, LLC
502308
In Commercial Distribution

  • M9935023080 ()

  • Height: 8 Millimeter


  • Orthopaedic bone fixation plate spacer
CEREC® Essentials with Celtra® Chairside Consumables Kit
DENTSPLY INTERNATIONAL INC.
61N002
Not in Commercial Distribution

  • D00261N0021 ()

  • 12 Blocks, 3 Firing Pads, 1 Syr. Calibra Ceram w/10 mix tips, 1 bottle Prime&Bond elect, 25 flocked app. tips, 1 disp. well, 1 syr. Coupling Agent w/25 disp. app. needles, 1 Stain & Glaze Kit
61N002

  • Dental appliance fabrication material, ceramic
ZenithDental Anterior/Posterior Hybrid Visible Light Cured Universal (u)
DMG AMERICA, LLC
61181
In Commercial Distribution

  • D033611811 ()

  • Weight: 3 Gram
003-61181

  • Dental composite resin
U SU DMD RND END TPR 856 18 SC
COLTENE/WHALEDENT INC
XU856SC018
Not in Commercial Distribution

  • D661XU856SC0181 ()
  • D661XU856SC0180 ()


  • Carbide dental bur, reusable
U SU DMD FLT END TPR 848 16 SC
COLTENE/WHALEDENT INC
XU848SC016
Not in Commercial Distribution

  • D661XU848SC0161 ()
  • D661XU848SC0160 ()


  • Carbide dental bur, reusable
022 MICRO TWIN ROTH 5x5 U&L W/HOOKS
Ortho Arch Company Inc
464-952
In Commercial Distribution

  • D9094649521 ()
464-952

  • Orthodontic bracket, metal
018 MICRO TWIN ROTH 5x5 U&L W/HOOKS
Ortho Arch Company Inc
464-950
In Commercial Distribution

  • D9094649501 ()
464-950

  • Orthodontic bracket, metal
018 MICRO TWIN MBT 5x5 U&L W/HOOKS
Ortho Arch Company Inc
464-940
In Commercial Distribution

  • D9094649401 ()
464-940

  • Orthodontic bracket, metal
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