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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™ 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
SNAP™ Intro Kit (1-Liquid & 4-Powders) with Russian Labeling (Kraftway)
PARKELL, INC.
S424-R
In Commercial Distribution

  • 00810000528233 ()
S424-R

  • Temporary dental crown/bridge resin
MucoHard™+ Primer Refill
PARKELL, INC.
S642
In Commercial Distribution

  • 00810000525690 ()
S642

  • Denture reliner, hard
MucoHard™+ Cartridge Refill
PARKELL, INC.
S641
In Commercial Distribution

  • 00810000525683 ()
S641

  • Denture reliner, hard
MucoHard™+ Kit
PARKELL, INC.
S640
In Commercial Distribution

  • 00810000525676 ()
S640

  • Denture reliner, hard
DIRECTVIEW CR Cassett with PQ Scrn 35x43
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with PQ Screen
In Commercial Distribution

  • 60889978413515 ()
  • 40889978413511 ()
8413510

  • Digital imaging cassette/phosphor plate
(2) SZ 1 DENTAL CR I/O IMAG PLATES
CARESTREAM HEALTH, INC.
Imaging Plate
In Commercial Distribution

  • 60889978406845 ()
  • 40889978406841 ()
  • 00889978406843 ()
8406845

  • Digital imaging storage phosphor screen
LANEX Regular SCR 1PR 13x18cm
CARESTREAM HEALTH, INC.
LANEX Regular Screens
In Commercial Distribution

  • 60889971976208 ()
  • 40889971976204 ()
1976208

  • X-ray intensifying screen
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