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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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Micro Ovd. Impression Coping. Records and transfer implant position to a working implant cast.
STERNGOLD DENTAL LLC
811236
In Commercial Distribution

  • 00841549116308 ()


  • Dental implant abutment impression cap
Micro Partial Impression Coping. Records and transfer implant position to a working implant cast.
STERNGOLD DENTAL LLC
811235
In Commercial Distribution

  • 00841549116292 ()


  • Dental implant abutment impression cap
ANGLE GAUGE KIT. Used to choose the ERA® Implant Abutments which best accommodate your case's planned path of insertion. Made from Titanium.
STERNGOLD DENTAL LLC
811193
In Commercial Distribution

  • 00841549116209 ()


  • Dental implantation depth/angle gauge, reusable
Micro Seating Tool. Manufactured from stainless steel to precisely carry and deliver male inserts to female ERA Attachments.
STERNGOLD DENTAL LLC
811022
In Commercial Distribution

  • 00841549116094 ()


  • Surgical torque wrench, reusable
Rose, Blue, Pink (1 of each). Light cured material for the preparation of custom trays.
STERNGOLD DENTAL LLC
222003
In Commercial Distribution

  • 00841549116025 ()


  • Dental impression tray material
Blue 50 sheets. Light cured material for the preparation of custom trays.
STERNGOLD DENTAL LLC
222002
In Commercial Distribution

  • 00841549116018 ()


  • Dental impression tray material
Rose 50 sheets. Light cured material for the preparation of custom trays.
STERNGOLD DENTAL LLC
222001
In Commercial Distribution

  • 00841549116001 ()


  • Dental impression tray material
4:1 Dispensing gun. A dispensing gun used for Instatemp Max composite, a tooth colored bis-acryl composite used to fabricate temporary crowns and bridges, long-term temporaries, provisional inlays, onlays and veneers.
STERNGOLD DENTAL LLC
220221
In Commercial Distribution

  • 00841549115998 ()


  • Dental material cartridge-plunging applicator, two-component, manual
Mixing tips 45 pcs. Mixing tips used for dispensing material from auto mix cartridges for Instatemp Max composite, a tooth colored bis-acryl composite used to fabricate temporary crowns and bridges, long-term temporaries, provisional inlays, onlays and veneers.
STERNGOLD DENTAL LLC
220220
In Commercial Distribution

  • 00841549115981 ()


  • Dental material mixing nozzle
Base and Catalyst (10ml each). An acrylate-based light cured liquid material that when applied to polymerized composite surfaces, custom trays or temporary crown and bridges and light cured, produces a hard, gloss surface which is solvent and resistant. It also may be used as an oxygen barrier to pre-polymerized acrylic materials that after polymenization which will prevent a remaining oxygen inhibited layer. An additional use is to act as an acrylic condition when applied to acrylic upon receiving subsequent layer of acrylic to aid in adhesion of all acrylic materials involved.
STERNGOLD DENTAL LLC
220182
In Commercial Distribution

  • 00841549115974 ()


  • Dental prosthesis priming agent
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