MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON 300 SERIES PACKAGE; SCALER, ULTRASONIC

Catalog Number	8161429
Medical Device Problem Code	Overheating of Device (1437)
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 cavitron 300 series package allegedly the sterimate and insert were heating up during use.No injury occurred.
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.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
Additional Manufacturer Narrative
Dhr review is not required because the product was returned for evaluation.The service technician could not replicate the failure noted in the complaint with the returned unit.No additional action is necessary.Refer to the repair notes below.Notes: 07/03/25 repair tech: (b)(6).000 evaluated, meets specifications, contact customer.Replaced damaged/worn components and recalibrated unit to factory specs.Qa-gb.Could not duplicate the complaint of hand piece heating up (not during use).Ran the unit for over 30 minutes and another 30 minutes with just the unit on and not in use without being able to duplicate the handpiece getting hot.Check your inserts for any clogging or damage.Make sure only 30k dentsply sirona inserts are being used with this unit, any other brand can cause issues.Hp 10/2023, hdpc 10/2023.Within warranty? no.Within warranty? no.Within warranty? no.

• Brand Name: CAVITRON 300 SERIES PACKAGE
• 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: 22307557
• Report Number: 2424472-2025-00234
• Device Sequence Number: 7997776
• Product Code: ELC
• UDI-Device Identifier: D00381614291
• UDI-Public: D00381614291
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K150535
• 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): 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: 8161429
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/18/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown