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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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MucoHard™ Hard Denture Reline Kit
PARKELL, INC.
S487
Not in Commercial Distribution

  • 00810000525270 ()
S487

  • Denture reliner, hard
MucoHard™ Resin Refill Cartridge with Tips
PARKELL, INC.
S486
Not in Commercial Distribution

  • 00810000525263 ()
S486

  • Denture reliner, hard
MucoHard™ Bonding Liner with 6-Brushes & 6-Pipettes
PARKELL, INC.
S485
Not in Commercial Distribution

  • 00810000525256 ()
S485

  • Denture reliner, hard
All-Cure DuraFinish™ Composite Glaze
PARKELL, INC.
S296
In Commercial Distribution

  • 00810000525195 ()
S296

  • Dental unfilled resin sealant/coating
DuraFinish™ Composite Glaze
PARKELL, INC.
S295
Not in Commercial Distribution

  • 00810000525188 ()
S295

  • Dental unfilled resin sealant/coating
CS3500 SMALL TIP (5 PIECES)
CARESTREAM HEALTH, INC.
CS 3500 3D Scanner Small Tip
In Commercial Distribution

  • 60889976567883 ()
  • 00889976567881 ()
6567887

  • Dental milling system, CAD/CAM, chairside
CS3500 COLLAR PACKING (10 PIECES)
CARESTREAM HEALTH, INC.
CS 3500 3D Scanner Collar
In Commercial Distribution

  • 60889976567876 ()
  • 00889976567874 ()
6567879

  • Dental milling system, CAD/CAM, chairside
LANEX Medium SCR 20PR 8x10in NF
CARESTREAM HEALTH, INC.
LANEX Medium Screens
In Commercial Distribution

  • 60889971997654 ()
  • 00889971997652 ()
1997659

  • X-ray intensifying screen
Point-of-Care CR Cass W SCRN TYP A 25x30
CARESTREAM HEALTH, INC.
Point-of-Care CR Cassette with Screen Type A
In Commercial Distribution

  • 60889971880758 ()
1880756

  • Digital imaging cassette/phosphor plate
SGL 18X24CM DIRECTVIEW PQ SCR
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with PQ Screen
In Commercial Distribution

  • 60889971831989 ()
1831981

  • Digital imaging cassette/phosphor plate
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