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Sleep Appliances With Patient Monitoring

FDA product code PLC · 9 cleared devices

Class 2 Dental
Regulation
21 CFR 872.5570
Review panel
DE
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2016-08-10 – 2026-08-25

For the treatment of night time snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older while also measuring patient compliance to oral appliance therapy.

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