InjuryKMY

SURESMILE RETAINER

Received Jul 22, 2026

Report 1649995-2026-00043 · MDR key 25907703

Device

Generic name

Positioner, Tooth, Preformed

Manufacturer

Dentsply Sirona Orthodontics Inc.

Catalog number

ASSY-500015

Product problems

Sharp Edges

Patient

NA · Unknown

Laceration(s)

Narrative

Additional Manufacturer Narrative

SINCE THIS EVENT RESULTED IN A SERIOUS INJURY, IT IS REPORTABLE PER 21 CFR PART 803.THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LOT NUMBER WAS PROVIDED AND RETAINED-PRODUCT TESTING AND/OR DHR REVIEW ARE PLANNED. THE RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

Description of Event or Problem

IN THIS EVENT IT IS REPORTED THAT THE PATIENT EXPERIENCED CUTTING OF THEIR GINGIVA AND BLEEDING FROM THE SURESMILE RETAINER.