Reveal® Clear Aligners 140-8735Recalls & reported problems
Ortho Organizers, Inc. · Reveal® Clear Aligners Standard Package · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00190707096946), received between Oct 2, 2023 and Apr 23, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).
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
- Insufficient Device Problem Information2
Patient problems
- Hypersensitivity/Allergic reaction1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 23, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE 77-YEAR-OLD FEMALE ALIGNER PATIENT PRESENTED WITH AN ALLERGIC REACTION. THE PATIENT STOPPED WEARING THE ALIGNER TRAYS THREE SEPARATE TIMES WITH SEVERAL DAYS IN BETWEEN AND RINSING THE ALIGNERS WITH DAWN SOAP AS ADVISED BY THE DENTAL OFFICE, BUT COULD NOT TOLERATE THE ALIGNERS DUE TO REDNESS OF THE ORAL TISSUE, SWELLING OF THE TONGUE, DIFFICULTY BREATHING, AND TENDER CHAPPED LIPS.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 19168718 ↗InjuryOct 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
PATIENT REPORTED HE TRIED TO WEAR THE STEP 1 MAXILLARY TRAY FOR 2-3 DAYS, BUT DISCONTINUED BECAUSE OF JAW PAIN DESPITE TAKING IBUPROFEN. HE WAS ABLE TO TOLERATE THE LOWER TRAY. ACCORDING TO THE DOCTOR'S OFFICE, THEY INITIALLY INSTRUCTED THE PATIENT NOT TO BITE THE TRAYS IN AT INSERTION. THE PATIENT THOUGHT HE SHOULD NOT BE BITING AT ALL WHILE WEARING THE ALIGNERS, SO HE KEPT OPENING HIS MOUTH. ACCORDING TO THE DOCTOR'S OFFICE, THIS COULD HAVE CONTRIBUTED TO TMJ PAIN. HE TRIED TO WEAR THE TRAYS AGAIN, BUT COULDN'T BECAUSE OF SORENESS AROUND HIS TEETH.
Patient problems: Pain
MAUDE report 17852343 ↗
Other Aligner, sequential devices
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- Byte Night Aligners NBYTETrayStraight Smile LLC · Aligner, Sequential1 recall6,053 reports
- sequential aligner 100-0352Access Dental Lab, LLC · Aligner, Sequential322 reports
- Invisalign System - Comprehensive 9000Align Technology, Inc. · Aligner, Sequential239 reports
- SureSmile® 1000Orametrix, Inc. · Aligner, Sequential134 reports
- REFINEMENT CORRECTION KIT 100-0012Access Dental Lab, LLC · Aligner, Sequential120 reports
- Candid Aligner FA-0001Candid Care CO. · Aligner, Sequential54 reports
- 3M™ Clarity™ 359-8353m Unitek Corporation · Aligner, sequential1 recall0 reports
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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