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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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Bond Aligner® is intended for use as an orthodontic bonding adhesive for brackets and appliances to thermoplastic aligner surfaces. Can also be used for forming button attachments. Bond Aligner is formulated to work with clear, thermoforming aligner plastics. It is not recommended for use with cloudy (Class C) thermoforming materials. Bond Aligner is a clear, light cure adhesive to adhere metal, ceramic or plastic attachments to a thermoplastic aligner.
RELIANCE ORTHODONTIC PRODUCTS INC
BA
In Commercial Distribution

  • D798BA0 ()
BA

  • Orthodontic bracket adhesive
The ASK, All surface bonding Kit is intended for use to increase adhesion to normal, atypical (wet or dry) enamel surfaces (hypocalcified, fluorosed, deciduous enamel, dentin), sandblasted metal (amalgam, gold or stanless steel), porclain, zirconia, composite restorations and acrylic temporary/pontic teeth. The ASK kit contains the Etchmaster 4 Hole Handpiece adapter with both lingual and regular tips for microetching, when required. The Assure Plus Bonding Resin included will bond to all intraoral surfaces, including zironia. Porcelain conditioner is provided for bonding to porcelain surfaces.
RELIANCE ORTHODONTIC PRODUCTS INC
ASK
In Commercial Distribution

  • D798ASK0 ()
ASK

  • Dentine bonding agent/set
  • Dental abrasive air jet system
Assure® Universal Bonding Resin is hydrophilic so the etched enamel can be dry or slightly contaminated with saliva. Assure® Universal Bonding Resin does not require light activation (except on dentin). It can be used under any chemical, light cure or dual cure paste, regardless of manufacturer. .
RELIANCE ORTHODONTIC PRODUCTS INC
AS2ML
In Commercial Distribution

  • D798AS2ML0 ()
AS2ML

  • Dentine bonding agent/set
The Reliance Button Hook Aligner Attachments are intended for use in securing a Class II elastic to a thermoplastic aligner or enamel surface.
RELIANCE ORTHODONTIC PRODUCTS INC
ABUT
In Commercial Distribution

  • D798ABUT0 ()
ABUT

  • Dental mould
The aligner attachment kit is intended for use in the creation of molds for thermoplastic alligners. The Oval Attachment Form can be used for the retention of the thermoplastic aligners and for horizontal or vertical placement on the tooth depending on the height of the crown. The Rectangle Attachment Form can be used for individual tooth movement and for extrusion of teeth. The Assure Bonding Resin included will bond to all intraoral surfaces without additional primers. L.C.R. Light Cure Paste cures smooth as glass for patient comfort. It has a very high Barcol Hardness for long term durability.
RELIANCE ORTHODONTIC PRODUCTS INC
A2
Not in Commercial Distribution

  • D798A20 ()
A2

  • Orthodontic aligner auxiliary attachment kit
  • Dental mould
  • Dentine bonding agent/set
Active Plate Bender-Cervical
NEXUS SPINE, L.L.C.
821044
In Commercial Distribution

  • B6788210440 ()
  • B678821044 ()


  • Manual orthopaedic bender, reusable
PreView Plate Bender
NEXUS SPINE, L.L.C.
821092
In Commercial Distribution

  • B6788210920 ()
  • B678821092 ()


  • Manual orthopaedic bender, reusable
PreView Plate Bender-Cervical
NEXUS SPINE, L.L.C.
821003
In Commercial Distribution

  • B6788210030 ()
  • B678821003 ()


  • Manual orthopaedic bender, reusable
ENDO MEASURING BLOCK
Premium Plus International Limited
4888
In Commercial Distribution

  • D83848888 ()
  • D83848882 ()


  • Surgical instrument interim-placement holder, reusable
Bur/endo organizers
Premium Plus International Limited
4812
In Commercial Distribution

  • D83848128 ()
  • D83848122 ()


  • Surgical instrument interim-placement holder, reusable
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