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e-CFR data is current as of September 17, 2020

Title 21Chapter ISubchapter HPart 872Subpart F → §872.5570


Title 21: Food and Drugs
PART 872—DENTAL DEVICES
Subpart F—Therapeutic Devices


§872.5570   Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.

(a) Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.

(b) Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”

[67 FR 68512, Nov. 12, 2002]

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