21 CFR 872.5570 — Device, Jaw Repositioning
Dental (DE) · Subpart F—Therapeutic Devices · § 872.5570
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.
Classification Rationale
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.”
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| LQZ | Device, Jaw Repositioning | 2 | 27 | 3rd Party |
| LRK | Device, Anti-Snoring | 2 | 210 | 3rd Party |
| MYB | Pillow, Cervical (For Mild Sleep Apnea) | 2 | 6 | 3rd Party |
| OHP | Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea | 2 | 5 | 3rd Party |
| ORY | Tongue Suspension System | 2 | 10 | Implant |
| OZR | Intraoral Pressure Gradient Device | 2 | 6 | 3rd Party |
| PLC | Sleep Appliances With Patient Monitoring | 2 | 9 | 3rd Party |
Special Controls
LQZ — Device, Jaw Repositioning
*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.”
eCFR
LRK — Device, Anti-Snoring
*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.”
eCFR
MYB — Pillow, Cervical (For Mild Sleep Apnea)
*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.”
eCFR
OHP — Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
*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.”
eCFR
ORY — Tongue Suspension System
*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.”
eCFR
OZR — Intraoral Pressure Gradient Device
*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.”
eCFR
OZR — Intraoral Pressure Gradient Device
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.”
Ecfr Llm
PLC — Sleep Appliances With Patient Monitoring
*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.”
eCFR
