MAUDE Adverse Event Report: DENTSPLY LLC STERI-MATE 30K HDPC. 1-PAK(DNA); SCALER, ULTRASONIC

Catalog Number	78688
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There has been a previous report received where lack of water flow has caused an overheating insert.Since an overheating insert could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur.As such, this event meets the criteria for reportability 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.
Event or Problem Description
While using a steri-mate they allege that they have no water flow or vibration and the insert tips are heating up, no injury resulted.
Additional Manufacturer Narrative
Product was not returned and unable to review dhr due to lack of information provided the lot number information required for a device history record (dhr) review was not provided.The user was instructed to immediately discontinue use of the product.

• Brand Name: STERI-MATE 30K HDPC. 1-PAK(DNA)
• Common Device Name: SCALER, ULTRASONIC
• 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 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 22793885
• Report Number: 2424472-2025-00100
• Device Sequence Number: 20993349
• Product Code: ELC
• UDI-Device Identifier: D00381614281
• UDI-Public: D00381614281
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K052334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 78688
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown