MAUDE Adverse Event Report: LARES RESEARCH LARES RESEARCH; 1:5 CONTRA ANGLE DENTAL HANDPIECE

Model Number	SMOOTHDRIVE
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation of the device did not provide a clear indication of the heat the doctor reported.The device operated within specification, but there was marks on the head cap indicating there may have been contact with the chuck actuator during operation.If the user inadvertently depressed the head cap during use, it can contact the chuck actuator and generate heat.This hazard is clearly identified in the device instructions for use.
Event or Problem Description
Dr stated that he felt warmth and the patient indicated feeling the device became warm during operation.There was no additional medical treatment necessary.

• Brand Name: LARES RESEARCH
• Common Device Name: 1:5 CONTRA ANGLE DENTAL HANDPIECE
• Manufacturer (Section D): LARES RESEARCH; 295 lockheed avenue; chico CA 95973
• Manufacturer (Section G): LARES RESEARCH; 295 lockheed avenue; chico CA 95973
• Manufacturer Contact: bruce holderbein ; 295 lockheed avenue; chico, CA 95973 ; 5303451767
• MDR Report Key: 23420497
• Report Number: 2916440-2025-00008
• Device Sequence Number: 8281029
• Product Code: EGS
• UDI-Device Identifier: D950135020
• UDI-Public: D950135020
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K220874
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SMOOTHDRIVE
• Device Catalogue Number: 13502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2024
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown