SureSmileRecalls & reported problems across all models
Orametrix, Inc. · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 175
- Deaths reported
- 0
- Injuries reported
- 119
- Recalls
- 0
We found 3 models of SureSmile by Orametrix, Inc. in the FDA's device registry (GUDID). Together they are named in 175 adverse event reports in the FDA's MAUDE database, received between Jun 28, 2023 and Sep 30, 2026 — classified as 119 injuries, 56 malfunctions.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (96 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported SureSmile problems
Device problems
- Patient-Device Incompatibility96
- Sharp Edges61
- Inadequacy of Device Shape and/or Size15
- Device Appears to Trigger Rejection4
- Adverse Event Without Identified Device or Use Problem3
- Unintended Movement3
- Crack2
- Product Quality Problem2
Patient problems
- Hypersensitivity/Allergic reaction66
- Laceration(s)48
- Deformity/ Disfigurement29
- Tissue Breakdown16
- No Clinical Signs, Symptoms or Conditions15
- Tooth Fracture10
- Discomfort7
- Pain7
SureSmile models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SureSmile® 1000Aligner, Sequential134 reports
- SureSmile® 1000Positioner, Tooth, Preformed39 reports
- SureSmile® 2000Aligner, sequential2 reports
Recent SureSmile adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Sharp Edges
It was reported that SURESMILE RETAINER had a protruding tip that caused discomfort to the patient.
Patient problems: Discomfort
MAUDE report 50945339 ↗InjurySep 29, 2026Device Appears to Trigger Rejection
It was reported that a patient experienced a possible allergic reaction.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 50936731 ↗InjurySep 23, 2026Crack; Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Sharp Edges
It was reported that SURESMILE RETAINER cracked causing a sharp edge.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870935 ↗InjurySep 23, 2026Crack; Product Quality Problem; Sharp Edges
It was reported that SURESMILE RETAINER cracked causing a sharp edge.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870317 ↗InjurySep 1, 2026Inadequacy of Device Shape and/or Size; Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50554128 ↗InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem; Unintended Movement
It was reported that a SURESMILE RETAINER caused gaps in patients lower teeth which also led to headaches. Patient's headache and gaps have been resolved by ordering new trays.
Patient problems: Headache
MAUDE report 50421600 ↗InjuryAug 24, 2026Structural Problem; Adverse Event Without Identified Device or Use Problem
It was reported that a SURESMILE RETAINER caused tooth resorption during treatment requiring a root canal.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50421499 ↗InjuryAug 24, 2026Unintended Movement
It was reported that a SURESMILE RETAINER has caused anterior Open bite.
Patient problems: Deformity/ Disfigurement
MAUDE report 50413087 ↗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 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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