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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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Unigraft is made of synthetic bioactive glass material. The product is conveniently packaged in a sterile vial and stored within a hermetically sealed foil pouch to ensure product sterility prior to implantation. Unigraft offers an osteogenic framework for new bone growth and bolsters a higher level of osteoblastic activity to enhance bone regeneration. FDA has cleared this product for use in treating periodontal defects, extractions sites, sinus elevation, apicoectomy and root resection, cranial and facial augmentation and augmentation of the alveolar ridges.
UNICARE BIOMEDICAL INC.
200-600um 1.0g
In Commercial Distribution

  • D767U0302051 ()
  • D767U030201 ()
U03-0205

  • Synthetic bone graft
Unigraft is made of synthetic bioactive glass material. The product is conveniently packaged in a sterile vial and stored within a hermetically sealed foil pouch to ensure product sterility prior to implantation. Unigraft offers an osteogenic framework for new bone growth and bolsters a higher level of osteoblastic activity to enhance bone regeneration. FDA has cleared this product for use in treating periodontal defects, extractions sites, sinus elevation, apicoectomy and root resection, cranial and facial augmentation and augmentation of the alveolar ridges.
UNICARE BIOMEDICAL INC.
200-600um 0.4g
In Commercial Distribution

  • D767U0301051 ()
  • D767U030101 ()
U03-0105

  • Synthetic bone graft
Unigraft is made of synthetic bioactive glass material. The product is conveniently packaged in a sterile vial and stored within a hermetically sealed foil pouch to ensure product sterility prior to implantation. Unigraft offers an osteogenic framework for new bone growth and bolsters a higher level of osteoblastic activity to enhance bone regeneration. FDA has cleared this product for use in treating periodontal defects, extractions sites, sinus elevation, apicoectomy and root resection, cranial and facial augmentation and augmentation of the alveolar ridges.
UNICARE BIOMEDICAL INC.
200-400um 1.0g
In Commercial Distribution

  • D767U0102051 ()
  • D767U010201 ()
U01-0205

  • Synthetic bone graft
Unigraft is made of synthetic bioactive glass material. The product is conveniently packaged in a sterile vial and stored within a hermetically sealed foil pouch to ensure product sterility prior to implantation. Unigraft offers an osteogenic framework for new bone growth and bolsters a higher level of osteoblastic activity to enhance bone regeneration. FDA has cleared this product for use in treating periodontal defects, extractions sites, sinus elevation, apicoectomy and root resection, cranial and facial augmentation and augmentation of the alveolar ridges.
UNICARE BIOMEDICAL INC.
200-400um 0.4g
In Commercial Distribution

  • D767U0101051 ()
  • D767U010101 ()
U01-0105

  • Synthetic bone graft
Nanohybrid Composite contains a new ytterbium fluoride mono-dispersed nano-sized particle which combined with regular silica and barium glass composes a state of the art nano-filler system. Nanohybrid Composite is a high viscosity composite that will resist sticking to instruments, yet will have sufficient flow to adapt to the walls of the cavity preparation. Nanohybrid Composite is radio-opaque and provides high compressive and flexural strengths along with a low water uptake. Nanohybrid Composite meets the ISO 4049 standard (Type 1, Class 2). Color/Shade: D2. SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-syringe-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-3015
In Commercial Distribution

  • D77819930150 ()

  • Weight: 4.5 Gram
199-3015

  • Dental composite resin
Nanohybrid Composite contains a new ytterbium fluoride mono-dispersed nano-sized particle which combined with regular silica and barium glass composes a state of the art nano-filler system. Nanohybrid Composite is a high viscosity composite that will resist sticking to instruments, yet will have sufficient flow to adapt to the walls of the cavity preparation. Nanohybrid Composite is radio-opaque and provides high compressive and flexural strengths along with a low water uptake. Nanohybrid Composite meets the ISO 4049 standard (Type 1, Class 2). Color/Shade: C2. SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-syringe-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-3014
In Commercial Distribution

  • D77819930140 ()

  • Weight: 4.5 Gram
199-3014

  • Dental composite resin
Nanohybrid Composite contains a new ytterbium fluoride mono-dispersed nano-sized particle which combined with regular silica and barium glass composes a state of the art nano-filler system. Nanohybrid Composite is a high viscosity composite that will resist sticking to instruments, yet will have sufficient flow to adapt to the walls of the cavity preparation. Nanohybrid Composite is radio-opaque and provides high compressive and flexural strengths along with a low water uptake. Nanohybrid Composite meets the ISO 4049 standard (Type 1, Class 2). Color/Shade: B4. SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-syringe-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-3013
In Commercial Distribution

  • D77819930130 ()

  • Weight: 4.5 Gram
199-3013

  • Dental composite resin
Nanohybrid Composite contains a new ytterbium fluoride mono-dispersed nano-sized particle which combined with regular silica and barium glass composes a state of the art nano-filler system. Nanohybrid Composite is a high viscosity composite that will resist sticking to instruments, yet will have sufficient flow to adapt to the walls of the cavity preparation. Nanohybrid Composite is radio-opaque and provides high compressive and flexural strengths along with a low water uptake. Nanohybrid Composite meets the ISO 4049 standard (Type 1, Class 2). Color/Shade: B1. SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-syringe-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-3012
In Commercial Distribution

  • D77819930120 ()

  • Weight: 4.5 Gram
199-3012

  • Dental composite resin
Nanohybrid Composite contains a new ytterbium fluoride mono-dispersed nano-sized particle which combined with regular silica and barium glass composes a state of the art nano-filler system. Nanohybrid Composite is a high viscosity composite that will resist sticking to instruments, yet will have sufficient flow to adapt to the walls of the cavity preparation. Nanohybrid Composite is radio-opaque and provides high compressive and flexural strengths along with a low water uptake. Nanohybrid Composite meets the ISO 4049 standard (Type 1, Class 2). Color/Shade: A4. SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-syringe-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-3011
In Commercial Distribution

  • D77819930110 ()

  • Weight: 4.5 Gram
199-3011

  • Dental composite resin
Nanohybrid Composite contains a new ytterbium fluoride mono-dispersed nano-sized particle which combined with regular silica and barium glass composes a state of the art nano-filler system. Nanohybrid Composite is a high viscosity composite that will resist sticking to instruments, yet will have sufficient flow to adapt to the walls of the cavity preparation. Nanohybrid Composite is radio-opaque and provides high compressive and flexural strengths along with a low water uptake. Nanohybrid Composite meets the ISO 4049 standard (Type 1, Class 2). Color/Shade: Opaque. SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-syringe-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-3010
In Commercial Distribution

  • D77819930100 ()

  • Weight: 4.5 Gram
199-3010

  • Dental composite resin
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