SSW CARBIDE FG-PBUR-330 (REF 15001)Recalls & reported problems
Ss White Burs, Inc. · FG CARBIDE 330 - 10 PACK · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI D690150012), received between May 5, 2025 and May 5, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unintended Ejection” (1 report).
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
- Unintended Ejection1
Patient problems
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 5, 2025Unintended Ejection; Unintended Ejection
ON (B)(6) 2025, CUSTOMER REPORTED THAT DURING A PROCEDURE, THE BUR EJECTED OUT OF HANDPIECE CAUSING SMALL GINGIVAL LACERATION. IT WAS FURTHER REPORTED THAT THE HANDPIECE WAS SET ASIDE, AND BUR WAS REMOVED. SS WHITE BURS LLC RECEIVED THE MEDWATCH #MW5168269 REPORT FROM THE FDA ON APRIL 8, 2025.
Patient problems: Laceration(s)
MAUDE report 21962459 ↗
Other BUR, DENTAL devices
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- TC cavity Burs Round E012334101200MAILLEFER INSTRUMENTS HOLDING Sàrl · BUR, DENTAL3 reports
- NA 1607002107Stryker Corporation · BUR, DENTAL3 reports
- NA 2296101421Stryker Corporation · BUR, DENTAL3 reports
- TC cavity Burs Round E012324101400MAILLEFER INSTRUMENTS HOLDING Sàrl · BUR, DENTAL2 reports
- NA 2296100212Stryker Corporation · BUR, DENTAL2 reports
- TC cavity Burs Round E012334101400MAILLEFER INSTRUMENTS HOLDING Sàrl · BUR, DENTAL2 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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