The Panthera Anti-Snoring Device 1Recalls & reported problems
Panthera Dentaire Inc · The Panthera D-SAD Classic is a removable intraoral device used for treating snoring and mild to moderate obstructive sleep apnea. It consists of two custom fabricated splints that fit separately over the upper and lower teeth. The device functions as a mandibular repositioner, maintaining the lower jaw in a forward position during sleep. This mechanical protrusion acts to increase the patient’s pharyngeal space, improving their ability to exchange air during sleep. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07540204000053), received between Nov 11, 2025 and Nov 11, 2025 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Anaphylactoid / Anaphylaxis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HE INITIALLY DEVELOPED SORES IN HIS MOUTH FROM THE APPLIANCE. HE WAS ADVISED TO DISCONTINUE CLEANING PRODUCT. PATIENT THEN ONLY USED WATER AND A BRUSH TO CLEAN IT. HE TRIED THE DEVICE AGAIN, DEVELOPED SORES INTRAORALLY, AND STARTED HAVING DIFFICULTY BREATHING. HE HAD AN ANAPHYLACTIC REACTION TO THE APPLIANCE AND HAD TO BE SEEN IN THE EMERGENCY ROOM.
Patient problems: Anaphylactoid / Anaphylaxis
MAUDE report 23526492 ↗
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- Pink Series - EF SP030USRespire Medical Holdings LLC · Device, Anti-Snoring1 report
- Respire Pink+ Hard SPP000USRespire Medical Holdings LLC · Device, Anti-Snoring1 report
- SICAT OPTISLEEP 10401SiCAT GmbH & Co. KG · Device, Anti-Snoring1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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