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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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). Delivery method is .3 Gm unit dose compules. Color/Shade: C1. SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-compules-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-4008
In Commercial Distribution

  • D77819940081 ()
  • D77819940080 ()

  • Weight: .3 Gram
199-4008

  • 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 a 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). Delivery method is .3 Gm unit dose compules. Color/Shade: B1. SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-compules-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-4007
In Commercial Distribution

  • D77819940071 ()
  • D77819940070 ()

  • Weight: .3 Gram
199-4007

  • 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). Delivery method is .3 Gm unit dose compules. Color/Shade: B2. SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-compules-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-4005
In Commercial Distribution

  • D77819940051 ()
  • D77819940050 ()

  • Weight: .3 Gram
199-4005

  • 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). Delivery method is .3 Gm unit dose compules. Color/Shade: A3.5. SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-compules-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-4004
In Commercial Distribution

  • D77819940041 ()
  • D77819940040 ()

  • Weight: .3 Gram
199-4004

  • 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). Delivery method is .3 Gm unit dose compules. Color/Shade: A3. SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-compules-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-4003
In Commercial Distribution

  • D77819940031 ()
  • D77819940030 ()

  • Weight: .3 Gram
199-4003

  • 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). Delivery method is .3 Gm unit dose compules. Color/Shade: A2. SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-compules-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-4002
In Commercial Distribution

  • D77819940021 ()
  • D77819940020 ()

  • Weight: .3 Gram
199-4002

  • 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). Delivery method is .3 Gm unit dose compules. Color/Shade: A1. SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-compules-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-4001
In Commercial Distribution

  • D77819940011 ()
  • D77819940010 ()

  • Weight: .3 Gram
199-4001

  • Dental composite resin
Compact, lightweight, portable, state of the art three-component force platform, measuring the vertical ground reaction force and its point of application (CoP). It is sensitive enough to pick up the changes in the vertical ground reaction force produced by the beating of the heart and the blood ejection in the aorta (including the modulation produced by the breathing cycle), while the subject is standing on the top surface. It satisfies the International Society for Posture and Gait Research (ISPGR) recommendations for clinical posturography. It is intended to be used as aid in fall risk screening; posturography (static and dynamic); weight, balance, and postural control assessment; and objective tracking of treatment efficacy and disease progress. Covered by one or more US patents.
VESTIBULAR TECHNOLOGIES, LLC
Lite
In Commercial Distribution

  • B702P32C0 ()
P32C

  • Stand-on floor scale, electronic
  • Posturography system platform
  • Posturography system
Lightweight, portable, state of the art three-component force platform, measuring the vertical ground reaction force and its point of application (CoP). Its large surface allows for any stance. It is sensitive enough to pick up the changes in the vertical ground reaction force produced by the beating of the heart and the blood ejection in the aorta (including the modulation produced by the breathing cycle), while the subject is standing on the top surface. It satisfies the International Society for Posture and Gait Research (ISPGR) recommendations for clinical posturography. It is intended to be used as aid in fall risk screening; posturography (static and dynamic); weight, balance, and postural control assessment; mechanography; physical performance investigations; and objective tracking of treatment efficacy and disease progress. Covered by one or more US patents.
VESTIBULAR TECHNOLOGIES, LLC
Professional
In Commercial Distribution

  • B702P31C0 ()
P31C

  • Biomechanical function analysis/interactive rehabilitation system
  • Posturography system
  • Posturography system platform
  • Stand-on floor scale, electronic
The Flight X-Vision Portable Handheld X-Ray is an ultra-safe state of the art system that has lower radiation levels than your traditional wall mounted x-rays. In addition, the ergonomic design allows the x-ray to be comfortably held in your hands and with one of the most intuitive and easy to use interfaces it makes doing a full mouth series even faster and more efficient. The X-Vision features the longest battery life on the market, with a full charge, it is able to take up to 800 shots with very low exposure times while producing the best quality images whether it’s on film, digital sensor or phosphorus plates. Finally, with the use of high quality components, from the Panasonic battery to the Toshiba tube head, made in Japan, the X-Vision is the workhorse X-Ray for every office.
Flight Dental Systems
XR-3800
In Commercial Distribution

  • D884XR3800 ()
X-Vision

  • Hand-held intraoral dental x-ray system, digital
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