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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DURAGUARD CLEAR .040(1mm) ROUND EACH
DENTSPLY SIRONA ORTHODONTICS INC.
DGSC040BR
Not in Commercial Distribution

  • D746DGSC040BR1 ()
DGSC040BR

  • Dental implant x-ray template
DURAGUARD BLUE .120(3mm) SQUARE EACH
DENTSPLY SIRONA ORTHODONTICS INC.
DGSB120BS
Not in Commercial Distribution

  • D746DGSB120BS1 ()
DGSB120BS

  • Dental implant x-ray template
Device to alleviate pain caused by bruxing or clenching of teeth
Prismatik Dentalcraft, Inc
COMSPL
In Commercial Distribution

  • D745COMSPL0 ()
COMSPL

  • Mouthguard, reusable
Single Dip Cassette Drug Test, PCP
Express Diagnostic Int'l, Inc.
30180C
In Commercial Distribution

  • B29830180C10 ()
30180C

  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
Single Dip Cassette Drug Test, PCP
EXPRESS DIAGNOSTICS INT'L, INC.
30180C
Not in Commercial Distribution

  • B29830180C0 ()
30180C

  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
Single Dip Drug Test, PCP
Express Diagnostic Int'l, Inc.
30180
In Commercial Distribution

  • B2983018010 ()
30180

  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
Single Dip Drug Test, PCP
EXPRESS DIAGNOSTICS INT'L, INC.
30180
Not in Commercial Distribution

  • B298301800 ()
30180

  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
Content: 1 piece Height: 25 mm. Used for the creation of bite splints, orthodontic splints and occlusal splints for bruxism.
ZIRKONZAHN SRL
TMIC1825
In Commercial Distribution

  • D800TMIC1825 ()


  • Dental bridge, polymer
Content: 1 piece Height: 20 mm. Used for the creation of bite splints, orthodontic splints and occlusal splints for bruxism.
ZIRKONZAHN SRL
TMIC1820
In Commercial Distribution

  • D800TMIC1820 ()


  • Dental bridge, polymer
Content: 1 piece Height: 16 mm. Used for the creation of bite splints, orthodontic splints and occlusal splints for bruxism.
ZIRKONZAHN SRL
TMIC1816
In Commercial Distribution

  • D800TMIC1816 ()


  • Dental bridge, polymer
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