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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Sensi Temp® Non-Eugenol Zinc Oxide Temporary Cement NEZO 5ml Syringe 10 Mix Tips
Sultan Healthcare Inc
70050
In Commercial Distribution

  • D687700501 ()

  • Total Volume: 5 Milliliter


  • Dental composite resin
Cinch™ Platinum Medium Body In Split-Cartridge No Clog Auto Mix System (4-Cartridges & Tips)
PARKELL, INC.
S454S
Not in Commercial Distribution

  • M595S454S1 ()
  • M595S454S0 ()
S454S

  • Silicone dental impression material
2x60g cart.,12 mix&12 oral tips. Medium viscosity polyvinyl siloxane precision impression material.
STERNGOLD DENTAL LLC
220121
In Commercial Distribution

  • 00841549115929 ()


  • Silicone dental impression material
CYP450 2C9 drug metabolizing enzyme and VKORC1 genotyping system
AUTOGENOMICS, INC
03-3140-01
Not in Commercial Distribution

  • 00850009370181 ()
03-3140-01

  • Anticoagulant-resistance multiple genetic risk factor IVD, kit, nucleic acid technique (NAT)
CYP2C19 drug metabolyzing enzyme genotyping system
AUTOGENOMICS, INC
03-3220-01
Not in Commercial Distribution

  • 00850009370150 ()
03-3220-01

  • Cytochrome P450 (CYP450) gene polymorphism IVD, kit, multiplex
No Description
BISCO INC.
F-6102
Not in Commercial Distribution

  • D757F61020 ()

  • sixe text
F-6102

  • Dentine bonding agent/set
No Description
BISCO INC.
F-6100D
Not in Commercial Distribution

  • D757F6100D1 ()

  • sixe text
F-6100D

  • Dentine bonding agent/set
No Description
HYCOR BIOMEDICAL LLC
118877-001
In Commercial Distribution

  • 00816879023091 ()


  • General laboratory container, reusable
1x50ml cart.15 mix&15 oral tips. Self-curing, tissue colored silicone, a gingival reproduction material.
STERNGOLD DENTAL LLC
222025
In Commercial Distribution

  • 00841549118524 ()


  • Silicone dental impression material
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-02
In Commercial Distribution

  • D801SP65021 ()
65-02

  • Dentine adhesive
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