Invisalign Express 10 8512Recalls & reported problems
Align Technology, Inc. · Aligner · Class 2
Data updated Oct 16, 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 00816063020042), received between Oct 9, 2024 and Mar 18, 2025 — classified as 2 injuries.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Bacterial Infection1
- Pain1
- Tooth Fracture1
- Tooth Loss1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE TREATING DOCTOR REPORTED THAT THE PATIENT'S TOOTH #12 BROKE AND IT IS NOW TREATMENT PLANNED FOR EXTRACTION. THE PATIENT IS STILL WEARING THE INVISALIGN TREATMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Tooth Fracture; Tooth Loss
MAUDE report 21630171 ↗InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF INFECTION, TOOTH MOBILITY, PAIN AND TRAUMA ON PERIODONTAL LIGAMENT. THE PATIENT REQUIRED VISITING A PERIODONTIST AND AN ORTHODONTIST WHO REFERRED PATIENT TO AN ENDODONTIST AND ORAL SURGEON FOR FURTHER TREATMENT, AND PRESCRIBED ORAL SURGERY. THE PATIENT WAS PRESCRIBED WITH THE FOLLOWING MEDICATION: PAIN MEDS, PERIODONTAL SPLINTS FOR STABILIZATION, ORAL SURGERY FOR ROOT RESORPTION AND FACIAL TRIGGER POINT INJECTIONS.
Patient problems: Bacterial Infection; Pain
MAUDE report 20413791 ↗
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™ 359-8343m 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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