WaveOne Gold Glider TSTW1GG321015Recalls & reported problems
Tulsa Dental Products LLC · WaveOne Gold Glider - 3pk - 21mm · Class 1
All models of WaveOne Gold Glider (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI D716TSTW1GG3210151), received between May 1, 2024 and May 27, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break6
Patient problems
- Device Embedded In Tissue or Plaque5
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 27, 2026Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD GLIDER 015-02/21MM BLISTER 3 US FILE BROKE DURING USE. ALL BROKEN PARTS HAVE BEEN RETRIEVED FROM PATIENT'S MOUTH. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25298715 ↗MalfunctionApr 20, 2026Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD GLIDER 015-02/25MM BLISTER 3 US FILE BROKE DURING USE. THE BROKEN PART REMAINS IN THE PATIENT'S TOOTH. PATIENT WILL BE KEPT UNDER OBSERVATION; TREATMENT OPTIONS WILL BE DISCUSSED WITH THE PATIENT THAT MAY INCLUDE RETREATMENT OR REMOVAL OF THE TOOTH. REPORTEDLY, NO INJURY. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 24923697 ↗MalfunctionMar 24, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD PRIMARY 3-FILE STER 21MM BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED, FILE REMAINS IN CANAL. REPORTEDLY, NO INJURY OCCURRED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21678547 ↗MalfunctionMar 19, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD GLIDER 015-02/21MM BLISTER 6 FILE BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED. NO INJURY OCCURRED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21643350 ↗MalfunctionMay 1, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD GLIDER 015-02/21MM BLISTER 6 BROKE DURING USE. THE DENTIST NO LONGER HAS THE INFORMATION ABOUT THE EXACT CIRCUMSTANCES OF THIS EVENT AND IF THE BROKEN PARTS HAVE BEEN RETRIEVED OR NOT. REPORTEDLY, NO INJURY OCCURRED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 19220426 ↗MalfunctionMay 1, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT WAVEONE GOLD GLIDER 015-02/21MM BLISTER 6 BROKE DURING USE. THE DENTIST NO LONGER HAS THE INFORMATION ABOUT THE EXACT CIRCUMSTANCES OF THIS EVENT AND IF THE PARTS HAVE BEEN RETRIEVED OR NOT. REPORTEDLY, NO INJURY OCCURRED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 19220336 ↗
Other FILE, PULP CANAL, ENDODONTIC devices
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- EdgeSequel Sapphire SES900425US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper SET25MMUS Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- Brasseler USA 5026667U0Peter Brasseler Holdings, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeOne Fire SEOFAST21US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- Edge File SX7300625RFUS Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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