# Tongue Suspension System
> **Product code: ORY** · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.5570
## Classification
- **FDA Product Code:** ORY
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 872.5570
- **Review panel:** DE
- **Medical specialty:** Dental
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** Y
- **Third-party review:** N
## Definition

Intended to be used for anterior advancement of the tongue base by means of a bone screw threaded with a suture.  It is indicated for the treatment of obstructive sleep apnea (OSA) and/or snoring.

## Market data
- **Cleared 510(k) submissions:** 10
- **Registered establishments:** 4
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=ORY)
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