MAUDE Adverse Event Report: DENTSPLY SIRONA ORTHODONTICS INC. SURESMILE RETAINER; POSITIONER, TOOTH, PREFORMED

Catalog Number	ASSY-500015
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that the suresmile retainer have sharp edges.
Additional Manufacturer Narrative
There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr 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.
Additional Manufacturer Narrative
A dhr review was conducted with no discrepancies noted.

• Brand Name: SURESMILE RETAINER
• Common Device Name: POSITIONER, TOOTH, PREFORMED
• Manufacturer (Section D): DENTSPLY SIRONA ORTHODONTICS INC.; 2350 campbell creek blvd. suit; richardson TX 75082
• Manufacturer (Section G): DENTSPLY SIRONA ORTHODONTICS INC.; 2350 campbell creek blvd. suit; richardson TX 75082
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 24400451
• Report Number: 1649995-2026-00006
• Device Sequence Number: 9748709
• Product Code: KMY
• UDI-Device Identifier: 00856379007269
• UDI-Public: 00856379007269
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: ASSY-500015
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/18/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown