ParaPost Fiber White PF180Recalls & reported problems
Coltene/Whaledent Inc · ParaPost Fiber White Intro Kit · 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 D661PF1801), received between Dec 27, 2019 and Dec 27, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Twisted/Bent” (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.
Most reported problems
Device problems
- Material Twisted/Bent1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 27, 2019Material Twisted/Bent; Material Twisted/Bent
FAULTY PRODUCT. BLUE DRILL, BENT FIRST TIME USED. USING TO DRILL ROOT FOR CAST POST TO BE MADE IN THE LAB.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9527243 ↗
Other Drill, Dental, Intraoral devices
- Neodent 103.170JJGC Indústria e Comércio de Materiais Dentários S/A. · DRILL, DENTAL, INTRAORAL1 recall0 reports
- Neodent 103.162JJGC Indústria e Comércio de Materiais Dentários S/A. · DRILL, DENTAL, INTRAORAL1 report
- Neodent 103.619JJGC Indústria e Comércio de Materiais Dentários S/A. · DRILL, DENTAL, INTRAORAL1 report
- ParaPost Fiber Lux PF170Coltene/Whaledent Inc · Drill, Dental, Intraoral1 report
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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