Is the SleepTight Mouthpiece FDA approved? FDA 510(k) Clearances Checked

Short answer: SleepTight Mouthpiece has 2 FDA 510(k) clearances on record, not an FDA approval. The most recent is K191618 ("SleepTight Mouthpiece STZ"), decided December 11, 2019 for Michael D Williams Dds PA (Davie, FL). The earliest in this list is K132506, decided May 29, 2014.

Product code: LRK (Device, Anti-Snoring, Class II, 21 CFR 872.5570)
Applicant as filed: Michael D Williams Dds PA
FDA decision on every record listed: Substantially Equivalent (cleared)

SleepTight Mouthpiece 510(k) records

FDA 510(k) records for SleepTight Mouthpiece
510(k) number	Device name (as filed)	Applicant	Decision date	Product code	Decision
K191618	SleepTight Mouthpiece STZ	Michael D Williams Dds PADavie, FL	December 11, 2019	LRK	Substantially Equivalent
K132506	SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASY	Michael D Williams Dds PADavie, FL	May 29, 2014	LRK	Substantially Equivalent

Each 510(k) number links to FDA's own record, where you can read the summary or statement and the intended use. We grouped these records under SleepTight Mouthpiece by device and applicant name; if a product you are looking at is sold under a different name, search the lookup or FDA's database directly.

Is SleepTight Mouthpiece "FDA approved"?

Not in FDA's sense of the word. Anti-snoring and jaw-repositioning mouthpieces are Class II devices that reach the market through a 510(k) premarket notification. FDA "clears" a 510(k) when it finds the device substantially equivalent to one already legally sold. "Approval" is a different process (premarket approval, or PMA) used mainly for higher-risk Class III devices. So the accurate phrase for SleepTight Mouthpiece is "FDA cleared", for the specific models and dates in the table above.

What this page is, and what it is not

This is a copy of public FDA records, not a review. 40 Winks has not tested these devices for this page.
A 510(k) clearance means FDA found a device substantially equivalent to a device already legally on the market. It is not an FDA approval, it is not an endorsement by FDA or by 40 Winks, and it does not show that a device will work for you. FDA's own rule (21 CFR 807.97) says a 510(k) clearance does not mean FDA has approved the device.
A clearance covers the specific device and model in the filing. Check that the product you are buying matches the 510(k) number and name, and read the intended use in FDA's record.
Loud, regular snoring can be a sign of obstructive sleep apnea. Talk to a doctor or a dentist trained in sleep medicine before relying on a mouthpiece, and ask whether a sleep test makes sense.

How to check a clearance yourself

Open FDA's 510(k) Premarket Notification database.
Search by the 510(k) number (it starts with K) or by the device or company name.
Open the record and read the device name, applicant, decision date and the linked summary or statement, which describes the intended use.
If a seller says "FDA approved" or "FDA cleared" but gives no 510(k) number, ask for it.

Other sleep devices in this lookup

Search all 254 sleep-appliance records in the FDA clearance lookup, or browse by product code: Anti-Snoring Devices (LRK), Jaw Repositioning Devices (LQZ), Sleep Appliances With Patient Monitoring (PLC).