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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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The ClearCorrect device is fabricated of clear thin thermoformed polyurethane plastic in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner.
Clearcorrect Operating, LLC
Aligner (Single-layer)
Not in Commercial Distribution

  • D865REF00051 ()
REF-05

  • Orthodontic progressive aligner
The ClearCorrect device is fabricated of clear thin thermoformed polyeurethane plastic in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner.
Clearcorrect Operating, LLC
Aligner (Single-Layer)
Not in Commercial Distribution

  • D865REF00011 ()
REF-01

  • Orthodontic progressive aligner
The ClearCorrect device is fabricated of clear thin thermoformed polyeurethane plastic in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner.
Clearcorrect Operating, LLC
MFG-0100 5.0
Not in Commercial Distribution

  • D865REF0001 ()
REF-01

  • Orthodontic progressive aligner
APDM's Opal V2C is a small worn monitor designed for documenting physical movement associated with applications in physiological monitoring. The Opal V2C can be used in any instance where quantifiable analysis of physical motion is desirable.
APDM, INC.
V2C
In Commercial Distribution

  • B628OPALV2C0 ()
OPALV2C

  • Kinesiology ambulatory recorder
Tangible Boost is a monthly treatment to restore the Tangible Hydra-PEG® coating, and maintain the wettability of Tangible Hydra-PEG coated fluorosilicone acrylate rigid gas permeable lenses. Tangible Boost is intended for prescription (Rx) use only.
TANGIBLE SCIENCE, LLC
A
In Commercial Distribution

  • B673FG6 ()
FG6

  • Contact lens rinsing solution
The reusable BE 130-23BB One-Way Valve is designed for use in any breathing circuit or ventilatory system where "back flow" must be avoided. It is designed to prevent the flow of gas back toward the source.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 130-23BB
In Commercial Distribution

  • M996BE13023BB5 ()
  • M996BE13023BB0 ()
  • M996BE13023BB2 ()


  • Non-rebreathing valve, reusable
The reusable BE 130-22B One-Way Valve is designed for use in any breathing circuit or ventilatory system where "back flow" must be avoided. It is designed to prevent the flow of gas back toward the source.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 130-22B
In Commercial Distribution

  • M996BE13022B5 ()
  • M996BE13022B0 ()
  • M996BE13022B2 ()


  • Non-rebreathing valve, reusable
The reusable BE 130 One-Way Valve is designed for use in any breathing circuit or ventilatory system where "back flow" must be avoided. It is designed to prevent the flow of gas back toward the source.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 130
In Commercial Distribution

  • M996BE1302 ()
  • M996BE1300 ()


  • Non-rebreathing valve, reusable
The Etchmaster system is intended for use for polishing, roughening, and/or etching of tooth surfaces, enamel, dentin, and dental restorations for adhesive restorative procedures. This is a 25 pack of the Etchmaster Small Lingual tips.
RELIANCE ORTHODONTIC PRODUCTS INC
EMTLS
In Commercial Distribution

  • D798EMTLS1 ()
  • D798EMTLS0 ()
  • D798EMTLS2 ()
  • D798EMTLS3 ()
EMTLS

  • Dental abrasive air jet system
INDICATIONS FOR USE: Custom IQ™ is intended for use as a chair-side, fast set, no mix chemical cure bonding resin for custom base indirect bonding. This is the Part A of the two part system.
RELIANCE ORTHODONTIC PRODUCTS INC
CIQA
Not in Commercial Distribution

  • D798CIQA0 ()
CIQA

  • Dentine bonding agent/set
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