MAUDE Adverse Event Report: DENTSPLY LLC **NUPRO REVOLV 90D SOFT MULTI (PD); HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL

Catalog Number	965250
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
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.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Event or Problem Description
In this event it is reported that nupro revolv 90d soft multi (pd) is alleged that patient had an allergic reaction to something during their cleaning.The hygienist thinks it is the prophy cup used during the polishing of the patients¿ teeth.A dentsply sirona nupro freedom- revolve prophy cup was used with a non-dentsply sirona polishing paste.Patient will see her allergist in (b)(6) 2025, as this is the soonest appointment available".No injury was reported from the alleged event.
Additional Manufacturer Narrative
Allergic reaction checklist was never received from the customer to further evaluate this incident.If additional information is received, we will reopen the complaint for further investigation.Root cause is inconclusive due to not enough information was provided by the customer.Failure mode - possible allergic reaction.Root cause - customer did not read/follow instructions.Conclusion code - indeterminable.

• Common Device Name: HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL
• Manufacturer (Section D): DENTSPLY LLC; 1301 smile way; york PA 17404
• Manufacturer (Section G): DENTSPLY LLC; 1301 smile way; york PA 17404
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 22327582
• Report Number: 2424472-2025-00235
• Device Sequence Number: 20935417
• Product Code: EGS
• UDI-Device Identifier: D0039652501
• UDI-Public: D0039652501
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K030603
• 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): 09/19/2025

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: 965250
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/24/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown