MAUDE Adverse Event Report: DENTSPLY LLC 30K FSI-SLI-FG-1000 INS,PKD; SCALER, ULTRASONIC

Catalog Number	82008
Medical Device Problem Code	No Flow (2991)
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.Investigation results return qty (b)(4), 25073, 30k fsi-sli-1000 fg-63, 00136238 bul per mfg.Date.Test method / gp005-wi02 inductance: gauge id# 5349 due: 12/31/2026 result 3.15 ¿ meets spec ¿ does not meet spec ¿ n/a tip condition: ¿ meets spec ¿ does not meet spec ¿ n/a stack condition ¿ meets spec ¿ does not meet spec ¿ n/a tested on: g130 gage id # (b)(4) due date: (b)(6) 2026 set pressure: 35 psi water flow: output: 35 psi - ¿ meets spec ¿ does not meet spec ¿ n/a spray: - ¿ meets spec ¿does not meet spec ¿ n/a water leak: ¿ hp sealing ring ¿ proximal ring ¿ distal ring ¿ seam leak ¿ n/a vibration: ¿ meets spec ¿ does not meet spec ¿ n/a grip condition: ¿ meet spec.¿ does not meet spec ¿ n/a other visual observation: insert tip is bent.Insert water temperature was tested on a digital thermometer i.D.# (b)(4).Due date: (b)(6) 2026.The temperature was 85.2 °f, no fault found with temperature.The specifications state the temperature is not to exceed 118.4°f.(per pds-8016 (rev 6).Insert tip temperature was tested on a digital thermometer i.D.# (b)(4).Due date: (b)(6) 2026.The temperature was 90.2°f, no fault found with temperature.The specifications state the temperature is not to exceed 118.4°f.(per pds-8016 (rev 6).Alleged event: confirmed not confirmed.
Event or Problem Description
In this event it is reported that a 30k fsi-sli-fg-1000 ins,pkd is alleged that there is no water flow.No injury occurred.

• Brand Name: 30K FSI-SLI-FG-1000 INS,PKD
• 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: 24662151
• Report Number: 2424472-2026-00617
• Device Sequence Number: 5055343
• Product Code: ELC
• UDI-Device Identifier: D003820081
• UDI-Public: D003820081
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K052334/K970
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

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: 82008
• Device Lot Number: 25073/63
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2026
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/10/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown