uLab Systems Dental Aligner FG0094 (UDI 00860002380056)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00860002380056), received between Apr 24, 2023 and Aug 16, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 16, 2023Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  WHO: THE DOCTORS OFFICE CALLED STATING THAT THE PATIENT HAD A POTENTIAL ALLERGIC REACTION DURING TREATMENT WITH THE USMILE ALIGNER. WHAT: THE PATIENT HAD A POTENTIAL ALLERGIC REACTION TO THE ZENDURA MATERIAL USED TO MANUFACTURE THE USMILE ALIGNER. WHEN: (B)(6) 2023. WHERE: THIS DOCTOR'S OFFICE NOTIFIED CLIENT SERVICES VIA A PHONE CALL THAT THEIR PATIENT HAD AN ALLERGIC REACTION TO THE ZENDURA MATERIAL WHY: CLIENT SERVICES REPLIED VIA EMAIL TO THE DOCTOR'S OFFICE AND PROVIDED THE MSDS SHEET FOR THE ZENDURA A AND FLX MATERIALS WHICH IS USED TO MANUFACTURER THE USMILE ALIGNERS. CLIENT SERVICES ALSO ASKED THE DOCTOR OFFICE IF THE PATIENT HAD ANY KNOWN ALLERGIES AND THE DOCTOR'S OFFICE REPLIED: PENDING RESPONSE. CONCLUSION: THE CAUSE OF THE PATIENT'S ALLERGIC REACTION IS UNDETERMINED. IT IS NOT KNOWN IF THE ALIGNER MATERIAL (ZENDURA FLX) OR OTHER MATERIALS USED DURING THE TREATMENT (ADHESIVES/ATTACHMENT BONDING/LATEX) CAUSED THE PATIENT'S ALLERGIC REACTION. PENDING RECEIPT OF THE PRODUCT PER RMA-0568 AND EVALUATION BY THE QUALITY ENGINEER. NO MOVEMENT AS OF (B)(6) 2023 (LABEL GENERATED ON (B)(6) 2023). ULAB SYSTEMS REPORTED THIS ALLERGIC REACTION AS AN EMDR THROUGH OUR WEBTRADER PRODUCT

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17557479 ↗
• InjuryApr 24, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  DOCTORS OFFICE CALLED TO STATE THAT THEIR PATIENT RECEIVED HER ALIGNERS AND VERY SHORTLY AFTER PLACING THE FIRST SET IN MOUTH HAD AN ALLERGIC REACTION. THE DOCTOR'S OFFICE WASHED AND RINSED THE ALIGNERS AND GAVE THEM BACK TO THE PATIENT AND SHE THEN HAD A SEVERE ALLERGIC REACTION IN WHICH SHE ALMOST HAD TO USE HER EPI-PEN. THE DOCTOR'S OFFICE HAS SWITCHED THE PATIENT TO CERAMIC BRACES AND DISCONTINUED TREATMENT WITH THE USMILE CLEAR ALIGNERS. THE DOCTOR'S OFFICE REQUESTED TO BE CREDITED FOR THE CASE AS THE PATIENT WAS ONLY ABLE TO USE 1 ALIGNER SET. A FULL CREDIT REQUEST WAS APPROVED AND SUBMITTED TO THE DOCTOR'S OFFICE. CLIENT SERVICES REPLIED VIA EMAIL TO THE DOCTOR'S OFFICE AND PROVIDED THE MSDS SHEET FOR THE ZENDURA FLX MATERIAL WHICH IS USED TO MANUFACTURER THE USMILE ALIGNERS AND THE MSDS SHEET FOR THE LIQUINOX CLEANER WHICH IS USED TO CLEAN THE USMILE ALIGNERS. CONCLUSION: THE CAUSE OF THE PATIENT'S ALLERGIC REACTION IS UNDETERMINED. THE DOCTOR'S OFFICE RESPONDED TO THE CLIENT SERVICES EMAIL WITH THE PATIENT'S KNOWN ALLERGIES/ALLERGIC REACTIONS.THE PATIENT ASSOCIATED WITH THIS COMPLAINT HAD AN ALLERGIC REACTION TO THE EITHER THE ALIGNER MATERIAL, ATTACHMENT MATERIALS, GLUES/

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16802448 ↗