FINISHING POINT RA REFILL
Received Jun 18, 2026
Report 2515379-2026-00106 · MDR key 25545547
Device
Generic name
Agent, Polishing, Abrasive, Oral Cavity
Manufacturer
Dentsply LlcCatalog number
624065
Lot number
00157508
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR 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.
Description of Event or Problem
IN THIS EVENT IT IS REPORTED THAT FINISHING POINT RA REFILL IS ALLEGED TO HAVE A LATCHING ISSUE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.