SureSmile® 1000 (REF ASSY-500011)Recalls & reported problems

Summary

The FDA's MAUDE database contains 134 adverse event reports that list this exact device (DI 00856379007023), received between Jun 28, 2023 and Jul 31, 2026 — classified as 92 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (77 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 134 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2026Sharp Edges

  Patient problems: Discomfort; Laceration(s)

  MAUDE report 50096693 ↗
• MalfunctionJul 31, 2026Sharp Edges

  Patient problems: Discomfort; Laceration(s)

  MAUDE report 50096673 ↗
• MalfunctionJul 30, 2026Sharp Edges

  Patient problems: Discomfort; Laceration(s)

  MAUDE report 50082813 ↗
• InjuryJul 28, 2026Patient-Device Incompatibility

  In this event it is reported that NONTEMPLATE ALIGNER ARCH that a patient was using for treatment caused unintended movement of their teeth. Compared to the original plan (movement centered on upper and lower front teeth), an unexpected gap (gap) occurred between the upper left first molar and the canine tooth, which was not planned to move, and abnormal movement occurred due to improper alignment force or poor observation.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50054018 ↗
• InjuryJul 28, 2026Patient-Device Incompatibility

  In this event it is reported that NONTEMPLATE ALIGNER ARCH that a patient was using for treatment caused unintended movement of their teeth. Compared to the original plan (movement centered on upper and lower front teeth), an unexpected gap (gap) occurred between the upper left first molar and the canine tooth, which was not planned to move, and abnormal movement occurred due to improper alignment force or poor observation.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50053971 ↗
• InjuryJul 28, 2026Sharp Edges

  In this event it is reported that a patient using the NONTEMPLATE ALIGNER ARCH, the aligners have sharp area in the lingual area. This issue was found on lower aligners #3 and #4. Clinician requested to have all lower aligners redone with design modified. The clinician advised the patient to apply Orojel and trim the sharp area off.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50053313 ↗
• InjuryJul 27, 2026Therapeutic or Diagnostic Output Failure

  In this event it is reported that there was a treatment planning issue for NONTEMPLATE ALIGNER ARCH for a patient. The first setup was delivered as a non-extraction plan. Consequently, the doctor raised a complaint and requested a revision. The second setup was then correctly processed as an extraction plan.

  Patient problems: Insufficient Information

  MAUDE report 50006127 ↗
• InjuryJul 13, 2026Patient-Device Incompatibility

  IN THIS EVENT IT IS REPORTED THAT NONTEMPLATE ALIGNER ARCH HAS CAUSED THE PATIENT TO EXPERIENCE OPEN BITE ON THE BUCCAL. REFINEMENTS ARE NEEDED TO IMPROVE THE BITE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25793354 ↗
• InjuryJul 13, 2026Patient-Device Incompatibility

  IN THIS EVENT IT IS REPORTED THAT NONTEMPLATE ALIGNER ARCH CAUSED A SEVERE OPEN BITE TO THE PATIENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25793175 ↗
• MalfunctionJun 29, 2026Sharp Edges

  IN THIS EVENT IT IS REPORTED THAT A PATIENT USING THE NON-TEMPLATE ALIGNER ARCH ALLEGEDLY EXPERIENCED THE ALIGNER INNER SURFACE OF ALL THEIR ALIGNERS CURVES INWARD TOWARD THE TONGUE THAT RESULTS IN DISCOMFORT AND SORENESS ALONG THEIR TONGUE. THEIR DENTIST ADVISED THEM TO FILE THE SHARP EDGES USING AN EMERY BOARD. NO INJURY OCCURRED.

  Patient problems: Laceration(s)

  MAUDE report 25652310 ↗
• MalfunctionJun 10, 2026Sharp Edges

  IN THIS EVENT IT IS REPORTED THAT A PATIENT USING THE NONTEMPLATE ALIGNER ARCH EXPERIENCED THE ALIGNERS UPPER AND LOWER TO HAVE A LEDGE THAT WAS ROUGH AND PUTTING PRESSURE ON GUMS. THE DOCTOR TRIMMED AND BUFFED THE ALIGNERS TO MAKE THEM SMOOTHER. NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25460632 ↗
• MalfunctionMay 14, 2026Sharp Edges

  IN THIS EVENT IT IS REPORTED THAT NON TEMPLATE ALIGNER ARCH - SURESMILE ALIGNERS - HAVE SHARP EDGES THAT ARE INJURING AND CUTTING THE PATIENT'S TONGUE. THE DOCTOR IS REQUESTING THE EDGES TO BE POLISHED, OR THAT THESE AREAS BE ADJUSTED SO THAT THEY MERELY GRAZE THE GUM TISSUE, THEREBY PREVENTING INJURY TO THE TONGUE.

  Patient problems: Laceration(s); Tissue Breakdown

  MAUDE report 25173828 ↗
• InjuryMay 12, 2026Patient-Device Incompatibility

  IN THIS CASE IT IS REPORTED THAT A PATIENT USING NONTEMPLATE ALIGNER ARCH EXPERIENCED BACK MOLARS THAT HAVE FLARED OUT THEN WHEN TREATMENT FIRST STARTED AND AN UNINTENDED POSTERIOR OPEN BITE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25149991 ↗
• MalfunctionApr 30, 2026Sharp Edges

  IN THIS EVENT IT IS REPORTED THAT A NONTEMPLATE ALIGNER ARCH THAT THE PATIENT WAS WEARING IS CUTTING THEIR MOUTH. THEY ARE BEING CUT IN THE UPPER PALATAL AND LOWER LINGUAL AREA OF THEIR MOUTH.

  Patient problems: Laceration(s)

  MAUDE report 25049296 ↗
• MalfunctionApr 27, 2026Patient-Device Incompatibility

  IN THIS EVENT IT IS REPORTED THAT A PATIENT EXPERIENCED MISALIGNMENT FROM NONTEMPLATE ALIGNER ARCH ALIGNER #10. REPORTEDLY, IT WAS DISCOVERED THE ISSUE WAS IN THE TREATMENT PLAN.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25001551 ↗
• MalfunctionFeb 11, 2026Sharp Edges

  IN THIS EVENT IT IS REPORTED THAT A PATIENT EXPERIENCED NON-TEMPLATE ALIGNER ARCH CAUSING BLEEDING. AFTER INVESTIGATION IT WAS FOUND THE ALIGNERS HAVE SHARP EDGES CAUSING THE BLEEDING.

  Patient problems: Laceration(s)

  MAUDE report 24317071 ↗
• MalfunctionFeb 10, 2026Patient-Device Incompatibility

  IN THIS EVENT IT IS REPORTED THAT A PATIENT USING THE NONTEMPLATE ALIGNER ARCH ALIGNERS EXPERIENCED ALLERGIC REACTION TO THE ALIGNERS. THE PATIENT EXPERIENCED RED AND IRRITATED GUMS WITH SORES AND BLISTERS THAT DEVELOPED ON THEIR LIPS. MULTIPLE CHANGES HAVE BEEN TRIED OVER THE PAST FEW MONTHS THAT HAVE NOT WORKED. THE ONLY RELIEF THE PATIENT GETS IS WHEN THEY DO NOT HAVE THE ALIGNERS IN THEIR MOUTH.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 24303810 ↗
• InjuryFeb 5, 2026Sharp Edges

  IN THIS EVENT IT IS REPORTED THAT THE NONTEMPLATE ALIGNER ARCH ALIGNERS CUTTING THE INSIDE OF THE PATIENT'S UPPER LIP. FURTHER INFORMATION REQUESTED.

  Patient problems: Laceration(s)

  MAUDE report 24267263 ↗
• InjuryJan 29, 2026Patient-Device Incompatibility

  IN THIS EVENT IT IS REPORTED THAT A PATIENT EXPERIENCED ALLERGIC REACTION TO THE NONTEMPLATE ALIGNER ARCH. PATIENT'S SYMPTOMS INCLUDED SWOLLEN LIPS, INSIDE LIPS THE AREA WAS VERY RED, LIPS WOULD BURN WHILE WEARING THE ALIGNERS. THE DOCTOR ALSO MENTIONED THAT THE PATIENT IS ALLERGIC TO BONDING AGENT AND WANTS TO SEE IF THE REACTION CAUSED BY THE ALIGNERS OR BONDING AGENT. FURTHER INFORMATION REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 24209086 ↗
• MalfunctionJan 19, 2026Patient-Device Incompatibility

  IN THIS EVENT IT IS REPORTED THAT PATIENT EXPERIENCED POSSIBLE ALLERGIC REACTION AND AN ORAL FUNGUS ON THE TONGUE AND IRRITATIONS ON BUCCAL MOLAR AREA NEAR TRIM LINE. DOCTOR HAD PATIENT STOP ALIGNER TREATMENT AND PRESCRIBED MEDICATION FOR THE ORAL FUNGUS, PATIENT TOOK MEDICATION FOR 1 WEEK AND IT CLEARED UP. PATIENT RESTARTED ALIGNERS AND THE SAME CONDITION CAME BACK WORSE. PATIENT COULD NOT EAT OR TALK. PATIENT'S PARENT TO THEM TO ANOTHER DENTIST WHO CONFIRMED IT WAS A FUNGUS AND PRESCRIPTION PRESCRIBED WAS CORRECT AND TO TAKE AGAIN. DOCTOR SPOKE WITH PATIENT'S PARENT WHO ADVISED THAT THE PRESCRIPTION IS NOT WORKING, NOT GETTING ANY BETTER. PATIENT WILL BE TAKEN TO FAMILY PHYSICIAN. FURTHER INFORMATION REQUESTED, ALLERGIC REACTION FORM AND ADDITIONAL INFORMATION REQUESTED AND RETURN OF REMAINING ALIGNERS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 24108671 ↗
• InjuryDec 22, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IN THIS EVENT IT IS REPORTED THAT A PATIENT USING NONTEMPLATE ALIGNER ARCH HAD ONE OF THEIR UPPER TEETH TO INTRUDE, UNINTENDED MOVEMENT OF THE TOOTH OCCURRED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23862720 ↗
• InjuryDec 16, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IN THIS EVENT IT IS REPORTED THAT A PATIENT EXPERIENCED AN ALLERGIC REACTION TO THE NONTEMPLATE ALIGNER ARCH ALIGNERS - SURESMILE ALIGNERS. PATIENT COMPLAINED OF FEELING ITCHY AROUND THEIR MOUTH AND BECAME VERY ITCHY AND RED ON THEIR CHEST.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 23819338 ↗
• InjuryDec 16, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IN THIS EVENT THAT WAS REPORTED ON A SOCIAL MEDIA SITE, THE PATIENT ALLEGES THAT THE NONTEMPLATE ALIGNER ARCH ALIGNERS KILLED THEIR TOOTH. THE TOOTH CANAL DETERIORATED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23819245 ↗
• InjuryDec 12, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IN THIS EVENT IT IS REPORTED THAT A PATIENT EXPERIENCED AN ALLERGIC REACTION TO THE NONTEMPLATE ALIGNER ARCH ALIGNERS. THE DOCTOR STATES THE PATIENT'S TONGUE WAS SCALING AND ROUGH. ONCE THE PATIENT STOPPED WEARING THE ALIGNERS THERE WAS IMPROVEMENT. PATIENT WAS ADVISED TO STOP TREATMENT IMMEDIATELY.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 23788531 ↗
• InjuryDec 4, 2025Patient-Device Incompatibility; Sharp Edges; Patient-Device Incompatibility; Sharp Edges

  IN THIS EVENT IT IS REPORTED BY THE PATIENT THAT A NONTEMPLATE ALIGNER ARCH - SURESMILE ALIGNER CAUSED CUTS AND IRRITATION TO THE PATIENT. PATIENT ALSO HAD COMPLAINTS OF ALIGNERS BREAKING AND NO ADJUSTMENT OF THE TREATMENT BEING MADE DESPITE THEIR REPEATED COMPLAINTS AND CATASTROPHIC OCCLUSION AND AN INCOMPLETE TREATMENT THAT IS FAR FROM SUCCESSFUL, RESULTING IN PHYSICAL, MORAL, AND FINANCIAL DAMAGE.

  Patient problems: Deformity/ Disfigurement; Inflammation; Laceration(s)

  MAUDE report 23717735 ↗