MAUDE Adverse Event Report: DENTSPLY LLC CAV.PLUS TAP-ON,220/240V,G136; SCALER, ULTRASONIC

Catalog Number	8184002
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that a cav.Plus tap-on,220/240v,g136 is alleged that the system is warm, because there is too little water.No injury.
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 results are not available as of this report.Evaluation results will be submitted as they become available.
Additional Manufacturer Narrative
Diagnosis.Waterway blocked.Repair report.The device was repaired, tested, and adjusted according to the manufacturer's specifications.The device was tested according to iec 62353 / din vde 0751.Solenoid valve and handpiece hose replaced.

• Brand Name: CAV.PLUS TAP-ON,220/240V,G136
• 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 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 23757877
• Report Number: 2424472-2025-00266
• Device Sequence Number: 10075716
• Product Code: ELC
• UDI-Device Identifier: D00381840021
• UDI-Public: D00381840021
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K052334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

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: 8184002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2025
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/14/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown