How to Check FDA Status of a Snoring Mouthpiece

An FDA listing or clearance is tied to a specific device and intended use. A broad product phrase such as “anti-snoring mouthpiece” does not identify the status of every model.

Verify the exact product

1. Record the device name, model or version, manufacturer, and any 510(k) number printed on the product page or package.
2. Search the FDA’s medical device clearance records by the device name, manufacturer, or 510(k) number.
3. Open the matching record and compare the device name and manufacturer with the product you are reviewing.
4. Read the record’s decision and intended-use statement. Check whether it describes snoring, obstructive sleep apnea, or another use.
5. Compare the labeled distribution status with the FDA record. FDA guidance says intraoral devices for snoring or obstructive sleep apnea are prescription devices unless the manufacturer develops adequate directions and FDA clears a 510(k) specifically for over-the-counter distribution.
6. Do not transfer a record from a similarly named device, another company, or a different version.

The FDA’s special controls guidance for intraoral devices describes this device category and the clearance pathway. For a concrete example of a device-specific record, see the FDA’s Zyppah 510(k) summary.

For material terminology on sleep products, see pillow fill materials and hybrid vs foam mattress construction. Browse sleep accessories.

This guide describes device labeling and regulatory records. Speak with a doctor about snoring, sleep breathing concerns, or questions about a medical device.

Sources

• Intraoral devices for snoring and/or obstructive sleep apnea, FDA
• Premarket notification database, FDA
• Zyppah 510(k) summary, FDA

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