MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON JET PLUS PACKAGE-2015; SCALER, ULTRASONIC

Catalog Number	8161428
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
In this event it is reported that a cavitron jet plus package-2015 is alleged to overheated and the inserts got hot during use.No injury.
Additional Manufacturer Narrative
Dhr review is not required because the product was returned for evaluation, and the described failure mode is a known hazard.Please refer to the repair notes below.01/14/2026 repair tech: (b)(6).Emh hp; cable, conn/gun cable damaged.No powder flow due to a blockage in the handpiece cable.Hardened and deteriorated air supply hose, clogged duckbill filter causing poor air/powder flow, flattened pinch tube restricting air/powder flow, powder bowl needs to be cleaned and retubed.Hardened and deteriorated water supply hose, debris buildup in the water filter.Replaced damaged/worn components and recalibrated unit to factory specs.Qa: tl.

• Brand Name: CAVITRON JET PLUS PACKAGE-2015
• 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: 23819373
• Report Number: 2424472-2025-00273
• Device Sequence Number: 10104708
• Product Code: ELC
• UDI-Device Identifier: D00381614281
• UDI-Public: D00381614281
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K052334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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: 8161428
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/09/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown