MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON 300 SERIES G310SCLR(DNA); SCALER, ULTRASONIC

Catalog Number	G310SCLR
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
While the customer was using a cavitron 300 series g310, they allege that the inserts are heating up.No injury was reported from the alleged event.
Additional Manufacturer Narrative
01/13/2026 evaluation tech: (b)(6).Edh dsp/if/ic/scan board damaged.Display is cracked all around the edges.Ran unit for 25 min without any issues; inserts didn't heat up; i suggest checking your inserts and be sure to use "30k dentsply sirona inserts" when using our units.Damaged handpiece cable; has holes throughout the cord.Wrong or missing water filter affecting water quality.Will replace damaged/worn components and recalibrate unit to factory specs upon estimate approval.St: 05/21.Hpc: 04/21.Dhr review is not required because the product was returned for evaluation, and the described failure mode is a known hazard.

• Brand Name: CAVITRON 300 SERIES G310SCLR(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: 23967306
• Report Number: 2424472-2025-00180
• Device Sequence Number: 9405673
• Product Code: ELC
• UDI-Device Identifier: D00382703101
• UDI-Public: D00382703101
• 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): 01/22/2026

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
• 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: 12/31/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 01/23/2026
• 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