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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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LuxaPrint Ortho Plus 385 - EDMG1712100

(Meth) acrylate-based light-curing resin exclusively for use in the dental laboratory. For DLP/ STL printers at a wavelength of 405 nm or 385 nm. High spirits in 3D. Content: 1 Bottle @ 500 g
DMG Chemisch-Pharmazeutische Fabrik GmbH
171210
Not in Commercial Distribution

  • EDMG1712101 ()
  • EDMG1712100 ()
171210

  • Dental appliance fabrication material, resin

LuxaPrint Ortho 405 - EDMG1712080

(Meth) acrylate-based light-curing resin exclusively for use in the dental laboratory. For DLP/ STL printers at a wavelength of 405 nm or 385 nm. High spirits in 3D. Content: 1 Bottle @ 500 g
DMG Chemisch-Pharmazeutische Fabrik GmbH
171208
Not in Commercial Distribution

  • EDMG1712081 ()
  • EDMG1712080 ()
171208

  • Dental appliance fabrication material, resin

LuxaPrint Ortho 385 - EDMG1712060

(Meth) acrylate-based light-curing resin exclusively for use in the dental laboratory. For DLP/ STL printers at a wavelength of 405 nm or 385 nm. High spirits in 3D. Content: 1 Bottle @ 500 g
DMG Chemisch-Pharmazeutische Fabrik GmbH
171206
Not in Commercial Distribution

  • EDMG1712061 ()
  • EDMG1712060 ()
171206

  • Dental appliance fabrication material, resin

LuxaPrint Tray - EDMG1712050

(Meth) acrylate-based light-curing resin exclusively for use in the dental laboratory. For DLP/ STL printers at a wavelength of 405 nm or 385 nm. High spirits in 3D. Content: 1 Bottle @ 1000 g
DMG Chemisch-Pharmazeutische Fabrik GmbH
171205
Not in Commercial Distribution

  • EDMG1712051 ()
  • EDMG1712050 ()
171205

  • Dental impression tray material

LuxaPrint Tray - EDMG1712040

(Meth) acrylate-based light-curing resin exclusively for use in the dental laboratory. For DLP/ STL printers at a wavelength of 405 nm or 385 nm. High spirits in 3D. Content: 1 Bottle @ 500 g
DMG Chemisch-Pharmazeutische Fabrik GmbH
171204
Not in Commercial Distribution

  • EDMG1712041 ()
  • EDMG1712040 ()
171204

  • Dental impression tray material

Insure Refill Kit - D7796020253

Insure Regular Refill Kit includes 5 (3 g) syringes of Insure Regular, 1 Simulcure Catalyst (dual-cure catalyst paste), 2 Cosmedent brushes (#1 and #3), and 25 White Nozzle dispensing tips in the Tray.
COSMEDENT, INC.
602025
In Commercial Distribution

  • D7796020253 ()
602025

  • Dental composite resin

Colonic Irrigation Kit - B482Z160

Colon Hydrotherapy Disposable Single-Use Kit, consisting of a large size Bulb Style Speculum with limiter and Obturator, a water inflow tube, a collapsible waste segmented hose and a 2.5 g sachet of lubricant.
TRANSCENDENCIAS COMERCIALES SL
Segmented Hose / Hydrokit with limiter
In Commercial Distribution

  • B482Z161 ()
  • B482Z160 ()
  • B482Z162 ()
Z-16

  • Colonic lavage kit, non-surgical

LuxaPrint Ortho 385 - EMDG1712070

(Meth) acrylate-based light-curing resin exclusively for use in the dental laboratory. For DLP/ STL printers at a wavelength of 405 nm or 385 nm. High spirits in 3D. Content: 1 Bottle @ 1000 g
DMG Chemisch-Pharmazeutische Fabrik GmbH
171207
Not in Commercial Distribution

  • EMDG1712071 ()
  • EMDG1712070 ()
171207

  • Dental appliance fabrication material, resin

PermaSoft® - D001N8125000

Contains one (1) 500 gram powder (Pink), one (1) 500 milliliter liquid, and one (1) 105 milliliter sealer
Dentsply International Inc.
Soft Denture Liner 500 G Kit Pink
Not in Commercial Distribution

  • D001N8125000 ()
N812500

  • Dental appliance fabrication material, resin

PermaSoft® - D001N8121000

Contains one (1) 120 gram powder (Clear), two (2) 60 milliliter liquids, and one (1) 30 milliliter sealer
Dentsply International Inc.
Soft Denture Liner 120 G Kit Clear
Not in Commercial Distribution

  • D001N8121000 ()
N812100

  • Dental appliance fabrication material, resin
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