MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON 300 SERIES G310; SCALER, ULTRASONIC

Catalog Number	G310SCLR
Medical Device Problem Code	Restricted Flow rate (1248)
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 cavitron 300 series g310, they allege that they have little water flow and the handpiece is getting warm; no injury resulted.
Additional Manufacturer Narrative
Rma-591847/warranty repair: (b)(6) 2025.Unit serial number: (b)(6).Foot pedal serial number - (b)(6).Sterimate/handpiece lot number - (n/a).Handpiece cable lot number - (11230).Repair tech: gpb.Qa: rb.Root cause: 000-no fault found-evaluated-meets specifications.Could not replicate the problem the customer has stated.The unit itself is up to date and runs according to manufacture specs.Furthermore, the power and vibration of the unit itself is up to date to manufacturing standards.Battery and syncing process is up to date and the battery is holding charge throughout testing and when turning the unit off and back on the foot pedal is still synced to the unit.When the foot pedal is taken of the usb foot pedal charger the foot pedal held battery charge throughout testing and did not lose any battery status throughout testing.Usb foot pedal charging cord is working in good condition to manufactured standards.Water pressure and water flow is up to the manufactured specs and no leaks throughout the unit itself and no leaks throughout the water supply hose and the handpiece cable.Please always inspect all used inserts that are dentsply sirona inserts.Make sure that the inserts are not worn or damaged or clogged and or bent.Please check any loose connections when plugin the components into the unit itself.Note: replaced damaged/worn components and recalibrated unit to factory specs.For proper evaluation and testing please always send in all parts that go along with the unit to be looked at.

• Brand Name: CAVITRON 300 SERIES G310
• 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: 22994261
• Report Number: 2424472-2025-00121
• Device Sequence Number: 13141451
• Product Code: ELC
• UDI-Device Identifier: D00382703121
• UDI-Public: D00382703121
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150535
• 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): 10/13/2025

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: G310SCLR
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 10/15/2025
• 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