InjuryKMY

SURESMILE RETAINER

Received Jun 29, 2026 · Event occurred Jun 23, 2026

Report 1649995-2026-00033 · MDR key 25652202

Device

Generic name

Positioner, Tooth, Preformed

Manufacturer

Dentsply Sirona Orthodontics Inc.

Catalog number

ASSY-500015

Lot number

12505753

Product problems

Patient-Device Incompatibility

Patient

49 YR · Female

Deformity/ Disfigurement

Narrative

Additional Manufacturer Narrative

SINCE THIS EVENT RESULTED IN A SERIOUS INJURY, IT IS REPORTABLE PER 21 CFR PART 803.THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

Description of Event or Problem

IN THIS EVENT IT IS REPORTED THAT A PATIENT USING SURESMILE RETAINER HAS EXPERIENCED THEIR TEETH TO UNINTENTIONALLY MOVE - UNINTENDED MOVEMENT. A REFINEMENT FOR PASSIVE ALIGNERS HAS BEEN REQUESTED.