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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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Renamel® Microhybrid Body A1, Syringe 5g
DeltaMed GmbH
6061A1
In Commercial Distribution

6061A1

  • Dental composite resin
Insure® Lite Automix, Syringe 8g
DeltaMed GmbH
605ACL
In Commercial Distribution

605ACL

  • Dental composite resin
Insure® Lite Pink Opaque, Syringe 3g
DeltaMed GmbH
605107
In Commercial Distribution

605107

  • Dental composite resin
Insure® Lite Yellow Opaque, Syringe 3g
DeltaMed GmbH
605106
Not in Commercial Distribution

605106

  • Dental composite resin
Insure® Lite Grey Light, Syringe 3g
DeltaMed GmbH
605104
Not in Commercial Distribution

605104

  • Dental composite resin
Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations. Also Provide Protection Against Irritants from Restoratives or Auxiliary Materials. Dentin Shade Syringe. Ziploc Bag. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 75-035 IZ
In Commercial Distribution

  • D801ID75035IZ1 ()
75-035

  • Dental cavity varnish
SciPharm CuRay Match Metal Primer for Veneers or Cast Restorations (Primet). Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 7010 I
In Commercial Distribution

  • D801ID7010I1 ()
70-10

  • Dental composite resin
CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Kit. Italian
SCIENTIFIC PHARMACEUTICALS, INC.
ID 60-05 I
In Commercial Distribution

  • D801ID6005I1 ()
60-05

  • Dentine adhesive
CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Enamel Primer Bottle. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 60-052 I
In Commercial Distribution

  • D801ID60052I1 ()
60-052

  • Dentine adhesive
CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Syringe. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 60-051 I
In Commercial Distribution

  • D801ID60051I1 ()
60-05

  • Dentine adhesive
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