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Fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also please note the regulation entitled Misbranding by reference to premarket notification 21 CFR Part 807. Ken Luco President 1419 Butternut Creek Road Kingston K7L 4V3 Canada Re K160477 Trade/Device Name The Luco Hybrid OSA Appliance Regulation Number 21 CFR 872. Type of Use Select one or both as applicable Prescription Use Part 21 CFR 801 Subpart D D Over-The-Counter Use 21 CFR 801 Subpart C CONTINUE ON A SEPARATE PAGE IF...
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How to fill out luco hybrid osa appliance

01
Start by preparing the necessary materials for filling out the LUCO Hybrid OSA Appliance: LUCO appliance kit, moldable silicone, mixing bowl, and measuring cup.
02
Clean and dry the LUCO appliance kit before starting the filling process.
03
Mix the moldable silicone according to the manufacturer's instructions. Typically, you need to mix equal parts of base and catalyst in the mixing bowl.
04
Place the mixed silicone into the measuring cup for easy pouring.
05
Slowly pour the silicone into the appropriate sections of the LUCO Hybrid OSA Appliance, ensuring all areas are adequately filled, but avoid overfilling to prevent excess material from leaking or affecting the fit.
06
Use a spatula or dental instrument to remove any excess silicone or bubbles from the filled sections and create a smooth surface.
07
Allow the silicone to set and cure according to the manufacturer's recommended time. This usually takes a few hours.
08
Once cured, carefully remove the appliance from the mold and inspect for any defects or imperfections.
09
If any adjustments or modifications are needed, use dental tools or polishers to make the necessary changes.
10
Clean the LUCO Hybrid OSA Appliance thoroughly before using, following the recommended cleaning instructions provided by the manufacturer.

Who needs luco hybrid osa appliance?

01
People suffering from obstructive sleep apnea (OSA) can benefit from using the LUCO Hybrid OSA Appliance.
02
Individuals who have been diagnosed with mild to moderate OSA may find the LUCO Hybrid OSA Appliance useful.
03
Patients who prefer an oral appliance over a continuous positive airway pressure (CPAP) machine for the treatment of OSA can consider using the LUCO Hybrid OSA Appliance.
04
Those who experience snoring, daytime sleepiness, and other symptoms related to OSA may find relief with the LUCO Hybrid OSA Appliance.
05
People who have tried other OSA treatment options without success or are looking for an alternative to surgical interventions can explore the use of the LUCO Hybrid OSA Appliance.
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Luco hybrid osa appliance is a piece of equipment that combines features of both traditional orthodontic appliances and clear aligners.
Orthodontists and dentists are required to file luco hybrid osa appliance for their patients who require orthodontic treatment.
To fill out luco hybrid osa appliance, the orthodontist or dentist must first take a mold of the patient's teeth, then create a treatment plan using the luco hybrid system.
The purpose of luco hybrid osa appliance is to straighten teeth and correct orthodontic issues in a more discreet and comfortable manner compared to traditional braces.
The information reported on luco hybrid osa appliance includes the patient's dental records, treatment plan, and progress notes.
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