ProGlider PROGLIDE25DEMORecalls & reported problems
Tulsa Dental Products LLC · PROGLIDER Roatary Glide Path FILE STERILE 25MM US-Demo · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI D716PROGLIDE25DEMO1), received between Jul 21, 2025 and Sep 3, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
Patient problems
- Device Embedded In Tissue or Plaque3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 3, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A PROGLIDER 6FILE STERILE 25MM FILE BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED AND IS STILL IN THE ROOT CANAL. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22950486 ↗MalfunctionJul 21, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A PROGLIDER 3FILE STERILE 25MM BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED AND THE PATIENT WAS REFERRED TO A SPECIALIST. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22553451 ↗MalfunctionJul 21, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A PROGLIDER 3FILE STERILE 25MM BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED. THE PATIENT WAS REFERRED TO AN ENDO SPECIALIST. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22553442 ↗
Other FILE, PULP CANAL, ENDODONTIC devices
- WaveOne Gold Rotary File WGPRIME25Tulsa Dental Products LLC · FILE, PULP CANAL, ENDODONTIC68 reports
- EdgeTaper SETF225US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall1 report
- EdgeSequel Sapphire SES900425US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper SET25MMUS Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- Brasseler USA 5026664U0Peter Brasseler Holdings, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- Edge File SX7200621RFUS Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeOne Fire SEOFPRI21US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES350431US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.