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

Catalog Number	ASSY-500015
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
While it is unknown if the device used in this case caused or contributed to the patient¿s symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material.Therefore, this event meets the criteria for reportability per 21 cfr part 803.
Event or Problem Description
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.
Additional Manufacturer Narrative
We reviewed the dhr for this (b)(6) / patient id # (b)(6) / site id # (b)(4), qty.(b)(4) items assy-500015 (retainers) were packaged by the first shift by auto bag and box operation on october 22, 2025, manufacturing supercell sc3, equipment pua-05.The sales order was inspected and met the acceptance criteria provided by qa.Incoming inspection.We reviewed the incoming inspection record for the material manufacturing of this so-(b)(6).· raw material: 1apl40c125-orx / lot# 10445159 / qty.Received = (b)(4) pcs, inspection date: september 02, 2025.The material was found to be acceptable for use in the manufacture of the sure smile product.

• 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: 23484354
• Report Number: 1649995-2025-00069
• Device Sequence Number: 10558640
• Product Code: KMY
• UDI-Device Identifier: 00856379007269
• UDI-Public: 00856379007269
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: ASSY-500015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/04/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown