SureSmile® 1000 (REF ASSY-500015)Recalls & reported problems
Orametrix, Inc. · Retainer · Class 1
Quick summary
The SureSmile 1000 retainer is a clear plastic dental retainer made by OraMetrix to hold teeth in place after orthodontic treatment. The 36 reports mostly describe the retainer not fitting or sitting properly, shifting teeth or leaving gaps and an open bite, plus sharp edges that cut the mouth and allergic reactions to the material. Reports describe 23 injuries, no deaths, and 13 malfunctions. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 39
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00856379007269), received between Nov 16, 2023 and Sep 30, 2026 — classified as 26 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (19 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.
Reports received per month
Most reported problems
Device problems
- Patient-Device Incompatibility19
- Sharp Edges14
- Inadequacy of Device Shape and/or Size6
- Adverse Event Without Identified Device or Use Problem3
- Unintended Movement3
- Crack2
- Product Quality Problem2
- Defective Device1
Patient problems
- Deformity/ Disfigurement12
- Laceration(s)10
- Hypersensitivity/Allergic reaction6
- Tissue Breakdown6
- No Clinical Signs, Symptoms or Conditions5
- Pain4
- Discomfort3
- Tooth Fracture3
Recent adverse event reports
The 25 most recent of 39 reports, 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 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 ↗MalfunctionJun 24, 2026Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT A PATIENT USING SURESMILE RETAINER EXPERIENCED THE RETAINER CAUSING AN EXTREME OPEN BITE.
Patient problems: Deformity/ Disfigurement
MAUDE report 25607946 ↗MalfunctionJun 10, 2026Patient-Device Incompatibility
IN THIS CASE IT IS REPORTED THAT THE SURESMILE RETAINER DOES NOT MATCH THE FINAL ALIGNER AND HAS RESULTED IN A CANT, UNINTENDED MOVEMENT OF PATIENT'S LOWER ANTERIOR TEETH.
Patient problems: Deformity/ Disfigurement
MAUDE report 25460933 ↗InjuryJun 1, 2026Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT THE PATIENT DURING USE OF THE SURESMILE RETAINER IS ALLEGED TO EXPERIENCED ALLERGIC REACTION TO THE RETAINER.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 25353700 ↗InjuryApr 15, 2026Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT PATIENT EXPERIENCED MOBILITY FROM THE WEARING OF SURESMILE RETAINER.
Patient problems: Deformity/ Disfigurement; Pain
MAUDE report 24888018 ↗MalfunctionApr 7, 2026Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT A PATIENT USING SURESMILE RETAINER EXPERIENCED UNINTENDED MOVEMENT OF THEIR TEETH. REFINEMENTS WERE REQUIRED FOR THIS PATIENT.
Patient problems: Deformity/ Disfigurement
MAUDE report 24798948 ↗InjuryApr 1, 2026Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT A PATIENT USING THE SURESMILE RETAINER EXPERIENCED HAVING AN ANTERIOR OPEN BITE, THE RETAINER DID NOT FIT. THE DOCTOR RESCANNED THE PATIENT AND WILL SUBMIT A NEW ORDER FOR THE RETAINER.
Patient problems: Deformity/ Disfigurement
MAUDE report 24755521 ↗MalfunctionMar 16, 2026Inadequacy of Device Shape and/or Size; Defective Device
IN THIS EVENT IT IS REPORTED THE PATIENT EXPERIENCED THE SURESMILE RETAINER BEING TOO TIGHT AND UPON REMOVING OF THE RETAINER THE PATIENT'S CROWN CAME OFF.
Patient problems: Deformity/ Disfigurement; Tooth Fracture
MAUDE report 24604335 ↗MalfunctionFeb 26, 2026Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT A PATIENT EXPERIENCED MOBILITY OF THEIR TEETH DURING THE USE OF THE SURESMILE RETAINERS.
Patient problems: Deformity/ Disfigurement
MAUDE report 24454027 ↗MalfunctionFeb 20, 2026Sharp Edges
IN THIS EVENT IT IS REPORTED THAT THE SURESMILE RETAINER HAVE SHARP EDGES.
Patient problems: Insufficient Information
MAUDE report 24400451 ↗InjuryNov 6, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT A PATIENT EXPERIENCED AN ALLERGIC REACTION TO THE SURESMILE RETAINER. PATIENT REPORTED THEIR LIPS WERE SWOLLEN AFTER THEY STARTED WEARING THE RETAINERS.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 23484354 ↗InjuryAug 21, 2025Sharp Edges; Sharp Edges
IN THIS EVENT IT IS REPORTED THAT PATIENT USING SURESMILE RETAINER, THE RETAINER WERE TOO TIGHT AND CUT THE PATIENT'S FRONT PALATE.
Patient problems: Laceration(s)
MAUDE report 22858536 ↗InjuryAug 12, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT WHILE A PATIENT USING THE SURESMILE RETAINER CHIPPED THEIR TOOTH WHEN REMOVING THE RETAINERS. THE RETAINERS WERE TOO TIGHT UPON INSERTION. THE DOCTOR PLACED A TEMPORARY CROWN AND IS GOING TO RESCAN THEN ORDER A NEW SET WHEN THE PERMANENT CROWN IS PLACED.
Patient problems: Tooth Fracture
MAUDE report 22787222 ↗InjuryAug 5, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT DURING USE OF SURESMILE RETAINER, THE RETAINER WAS TOO TIGHT TO REMOVE. WHEN IT WAS ATTEMPTED TO REMOVE IT CAUSED CHIPPING ON A RESTORATION OF A TOOTH.
Patient problems: Tooth Fracture
MAUDE report 22723225 ↗InjuryJul 30, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT A PATIENT USING A SURESMILE RETAINER; THE RETAINER CAUSED AN ANTERIOR OPEN BITE.
Patient problems: Deformity/ Disfigurement
MAUDE report 22668490 ↗InjuryJul 15, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT WAS REPORTED THAT A PATIENT EXPERIENCED GINGIVAL RECESSION, SIGNIFICANT PAIN AND DISCOMFORT WHILE WEARING THE SURESMILE RETAINER. THE PRESCRIBING DOCTOR INDICATED THAT A NEW SET WOULD NOT BE A VIABLE SOLUTION. ADDITIONALLY, NO TRIMLINE MODIFICATIONS ARE AVAILABLE TO ADDRESS THE ISSUE.
Patient problems: Discomfort; Pain; Tissue Breakdown
MAUDE report 22516276 ↗MalfunctionMar 28, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT A PATIENT EXPERIENCED BLEEDING OF UPPER ANTERIOR GUMS CAUSED BY THE SURESMILE RETAINER THAT WERE CUTTING THE GUMS. PATIENT WAS RE-SCANNED BY DOCTOR AND NEW RETAINERS HAVE BEEN ORDERED.
Patient problems: Laceration(s)
MAUDE report 21718167 ↗InjuryMar 26, 2025Sharp Edges; Sharp Edges
IN THIS EVENT IT IS REPORTED THAT A PATIENT WEARING SURESMILE RETAINER EXPERIENCED THE UPPER RETAINER IMPINGING AND CUTTING THE PATIENT'S SOFT TISSUE ON THE LINGUAL.
Patient problems: Laceration(s)
MAUDE report 21696312 ↗InjuryFeb 20, 2025Inadequacy of Device Shape and/or Size; Sharp Edges; Inadequacy of Device Shape and/or Size; Sharp Edges
IN THIS EVENT IT IS REPORTED THAT THE PATIENT EXPERIENCED DIFFICULTY REMOVING SURESMILE RETAINER THIS RESULTED TO INJURY TO THEIR GUMS.
Patient problems: Laceration(s)
MAUDE report 21422294 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.