FDA Cleared Dental and ENT Divisions 510K Medical Device cleared - - PowerPoint PPT Presentation

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FDA Cleared Dental and ENT Divisions 510K Medical Device cleared - - PowerPoint PPT Presentation

Nov 19, 2023 164 likes •401 views

FDA Cleared Dental and ENT Divisions 510K Medical Device cleared by the ENT and Dental Divisions of the FDA: 1) As a Mandibular Repositioner for treatment of Snoring and Sleep Apnea and (2)As a Nasal Dilator for improved breathing

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FDA Cleared

Dental and ENT Divisions

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510K Medical Device cleared by the

ENT and Dental Divisions

  • f the FDA:
  • 1) As a Mandibular Repositioner for

treatment of Snoring and Sleep Apnea and

  • (2)As a Nasal Dilator for improved breathing

through the nose.

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Opening the Throat

  • The Oasys treats the upper airway by pulling

the lower jaw and tongue forward to prevent the tongue from blocking airflow and strengthening the throat against collapse.

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Improves Breathing Through the Nose

  • It also treats Sleep Disordered Breathing by

addressing upper airway resistance in the nasal region.

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Tongue Repositioning

  • Lingual Tongue Buttons can be added for

posturing the tongue up and forward, and for tongue training and better swallowing.

  • Significant AHI reduction has been seen in

even very Severe OSA patients.

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Mandibular Advancement Nasal Dilation Tongue Repositioning

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Mandibular Advancement Nasal Dilation Tongue Repositioning

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Mandibular Advancement

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Mandibular Advancement

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Mandibular Advancement 6 – 15 mm Sliding Anterior Shield

LOCK

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LOCK WRENCH MM SCALE

Easy Sliding Advancement, Locking and Measurement

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Nasal Dilation

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Cottle Technique

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Nasal Dilation

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Nasal Dilation for Improved Breathing through the Nose FDA 510 Cleared By the ENT Divisions of the FDA

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Nasal Dilators

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Lips Over Nasal Dilators

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Nasal Dilators Side View

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Tongue Repositioning

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Tongue Repositioning

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Training for a Better Swallow Posterior Buttons to Lift the Tongue Up and Forward

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Optional Lingual Tongue Buttons

For Lifting and Repositioning the Posterior of the Tongue Up and Forward, For Tongue Training and Better Swallowing