ParaPost Fiber Lux PF170Recalls & reported problems

Coltene/Whaledent Inc · ParaPost FiberLux 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 D661PF1701), received between Sep 24, 2019 and Sep 24, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Dull, Blunt” (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

Dull, Blunt1
Fracture1
Improper or Incorrect Procedure or Method1
Insufficient Device Problem Information1
Material Too Rigid or Stiff1
Material Too Soft/Flexible1

Patient problems

Device Embedded In Tissue or Plaque1
No Consequences Or Impact To Patient1
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.

MalfunctionSep 24, 2019Fracture; Material Too Rigid or Stiff; Improper or Incorrect Procedure or Method; Dull, Blunt; Insufficient Device Problem Information; Material Too Soft/Flexible; Fracture; Material Too Rigid or Stiff; Improper or Incorrect Procedure or Method; Dull, Blunt; Insufficient Device Problem Information; Material Too Soft/Flexible
DR. (B)(6) WAS CEMENTING A POST IN TOOTH 21, AND BARELY PUSHED DOWN ON THE RHEOSTAT DRILL, AND IT BROKE IN THE PATIENT'S MOUTH. FIRST TIME USING KIT. BLUE DRILL IS STILL IN PATIENT'S MOUTH AND THEY LEFT IT IN AS A POST AND CEMENTED IT IN. DOCTOR WANTED US TO BE AWARE.
Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9109415 ↗

Device details

UDI-DI	`D661PF1701`
Brand	ParaPost Fiber Lux
Model	PF170
Company	Coltene/Whaledent Inc
Product code	DZA · Drill, Dental, Intraoral
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 18, 2024

Device type (GMDN): Pin/post dental drill bit

A shaft of metal, typically with a spiralled portion at the cutting end (a twist drill bit), intended to be attached to a motorized handpiece, or other power source, to create a precise round hole at the appropriate depth in teeth or bone of the oral cavity. This hole or slot is used to secure cast or preformed pins/posts for stabilizing and retaining operative dental appliances. This is a reusable device.

Other Drill, Dental, Intraoral devices

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1 recall0 reports
Neodent 103.162
JJGC Indústria e Comércio de Materiais Dentários S/A. · DRILL, DENTAL, INTRAORAL
1 report
Neodent 103.619
JJGC Indústria e Comércio de Materiais Dentários S/A. · DRILL, DENTAL, INTRAORAL
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ParaPost Fiber White PF180
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All Drill, Dental, Intraoral devices →

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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