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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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Plate Bender - Increase
UNIFIED SPINE, LLC
509719
In Commercial Distribution

  • M9935097190 ()

  • Plate Bender - Increase


  • Manual orthopaedic bender, reusable
Altor Safety 4-Ply Surgical Mask (Model:62232) Outer Case of 2,000 Masks
Altor Safety LLC
62232
In Commercial Distribution

  • G023622321Z2 ()
  • G023622321 ()
62232

  • Surgical/medical face mask, non-antimicrobial, single-use
Altor Safety 4-Ply Surgical Mask (Model:62232) Inner Carton of 50 Masks
Altor Safety LLC
62232
In Commercial Distribution

  • G023622320 ()
62232

  • Surgical/medical face mask, non-antimicrobial, single-use
Altor Safety 3-Ply Surgical Mask (Model:62222) Outer Case of 2,000 Masks
Altor Safety LLC
62222
In Commercial Distribution

  • G023622222Z2 ()
  • G023622222 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
Altor Safety 3-Ply Surgical Mask (Model:62222) Inner Carton of 50 Masks
Altor Safety LLC
62222
In Commercial Distribution

  • G023622221 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
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. This is the 4 gm volume. .
RELIANCE ORTHODONTIC PRODUCTS INC
BI4MLAS
In Commercial Distribution

  • D798BI4MLAS0 ()
BI4MLAS

  • Dentine bonding agent/set
Blue Gel Etchant is intended for use in etching the tooth surface. Product has high visibility blue color. Product contains BAC (Benzalchromium chloride). 5 gm syringe with 10 tips
RELIANCE ORTHODONTIC PRODUCTS INC
BEGS
In Commercial Distribution

  • D798BEGS1 ()
  • D798BEGS0 ()
BEGS

  • Dental etching solution
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 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 Unidose (single use) Assure Universal Bonding Resin included will bond to all intraoral surfaces, including zironia. Porcelain conditioner is provided for bonding to porcelain surfaces.
RELIANCE ORTHODONTIC PRODUCTS INC
ASKU
Not in Commercial Distribution

  • D798ASKU0 ()
ASKU

  • Dentine bonding agent/set
  • Dental abrasive air jet system
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
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