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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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KALORE™ - D0470035841

KALORE™ Syringes (2 mL/4 g) B3
Gc America Inc.
003584
In Commercial Distribution

  • D0470035841 ()

  • Total Volume: 2 Milliliter
003584

  • Light-cured dental restorative composite resin

KALORE™ - D0470035821

KALORE™ Syringes (2 mL/4 g) B1
Gc America Inc.
003582
In Commercial Distribution

  • D0470035821 ()

  • Total Volume: 2 Milliliter
003582

  • Light-cured dental restorative composite resin

Ceramco® iC - D00148501350

No Description
Dentsply International Inc.
Dentin Shade Stain SS-315
Not in Commercial Distribution

  • D00148501350 ()

  • Total Volume: 2 Milliliter
4850135

  • Dental appliance fabrication material, ceramic

Ceramco® iC - D00148501340

No Description
Dentsply International Inc.
Dentin Shade Stain SS-314
Not in Commercial Distribution

  • D00148501340 ()

  • Total Volume: 2 Milliliter
4850134

  • Dental appliance fabrication material, ceramic

Ceramco® iC - D00148501330

No Description
Dentsply International Inc.
Dentin Shade Stain SS-313
Not in Commercial Distribution

  • D00148501330 ()

  • Total Volume: 2 Milliliter
4850133

  • Dental appliance fabrication material, ceramic

Ceramco® iC - D00148501320

No Description
Dentsply International Inc.
Dentin Shade Stain SS-312
Not in Commercial Distribution

  • D00148501320 ()

  • Total Volume: 2 Milliliter
4850132

  • Dental appliance fabrication material, ceramic

Ceramco® iC - D00148501310

No Description
Dentsply International Inc.
Dentin Shade Stain SS-311
Not in Commercial Distribution

  • D00148501310 ()

  • Total Volume: 2 Milliliter
4850131

  • Dental appliance fabrication material, ceramic

Ceramco® iC - D00148501300

No Description
Dentsply International Inc.
Dentin Shade Stain SS-310
Not in Commercial Distribution

  • D00148501300 ()

  • Total Volume: 2 Milliliter
4850130

  • Dental appliance fabrication material, ceramic

Ceramco® iC - D00148501290

No Description
Dentsply International Inc.
Dentin Shade Stain SS-209
Not in Commercial Distribution

  • D00148501290 ()

  • Total Volume: 2 Milliliter
4850129

  • Dental appliance fabrication material, ceramic

Ceramco® iC - D00148501280

No Description
Dentsply International Inc.
Dentin Shade Stain SS-208
Not in Commercial Distribution

  • D00148501280 ()

  • Total Volume: 2 Milliliter
4850128

  • Dental appliance fabrication material, ceramic
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