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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No Description
ACCUTRON, INC.
33968-4
In Commercial Distribution

  • 00813830021622 ()
33968-4

  • Nitrous oxide quick-connect coupling, male
No Description
ACCUTRON, INC.
33968-3
In Commercial Distribution

  • 00813830021615 ()
33968-3

  • Nitrous oxide quick-connect coupling, male
No Description
ACCUTRON, INC.
33968-10
In Commercial Distribution

  • 00813830021608 ()
33968-10

  • Nitrous oxide quick-connect coupling, male
No Description
ACCUTRON, INC.
34668-CUSTOM
Not in Commercial Distribution

  • 90813830020154 ()
34668-CUSTOM

  • Nitrous oxide quick-connect coupling, male
Warmed Gutta Percha Obturation System
Meta Biomed Co., Ltd.
9033
Not in Commercial Distribution

  • 08806387890331 ()


  • Endodontic obturation system
Warmed Gutta Percha Obturation System
Meta Biomed Co., Ltd.
9040
Not in Commercial Distribution

  • 08806387890409 ()


  • Endodontic obturation system
Warmed Gutta Percha Obturation System
Meta Biomed Co., Ltd.
9034
Not in Commercial Distribution

  • 08806387890348 ()


  • Endodontic obturation system
A surgical and therapeutic device intended for a variety of soft-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber cable, two surgical handpieces and laser tips, a wireless footswitch and other accessories (power cords, tip holders, protective eyewear, screen protectors). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
Epic Q Laser System
In Commercial Distribution

  • 00647529004357 ()
7410008

  • Dental diode laser system
6Y-PSZ zirconium dioxide, pre-sintered white-fired condition. Ultra-high translucent, pre-shaded, multi-layered. Suitable for single crowns and/or bridges consisting of up to 3 units. Bending strength: 600 MPa (typical value)
DOCERAM medical ceramics GmbH
Pearl Q³ Multi-Shade C-Dark
Not in Commercial Distribution

  • EDMC34923000470 ()

  • Height: 20 Millimeter
3492300047

  • Dental appliance fabrication material, ceramic
6Y-PSZ zirconium dioxide, pre-sintered white-fired condition. Ultra-high translucent, pre-shaded, multi-layered. Suitable for single crowns and/or bridges consisting of up to 3 units. Bending strength: 600 MPa (typical value)
DOCERAM medical ceramics GmbH
Pearl Q³ Multi-Shade C-Dark
Not in Commercial Distribution

  • EDMC34923000460 ()

  • Height: 16 Millimeter
3492300046

  • Dental appliance fabrication material, ceramic
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