Diamond burs F016734201000Recalls & reported problems

MAILLEFER INSTRUMENTS HOLDING Sàrl · Dental Burs · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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 J003F0167342010001), received between Dec 6, 2024 and Dec 6, 2024 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

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.

MalfunctionDec 6, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT A DIAM.B.S.PREP.CONIC. FG M 010 BUR BROKE DURING USE. THE USER DOES NOT KNOW WHAT HAPPENED TO THE BROKEN PART. IT IS ASSUMED THAT THEY WERE SWALLOWED BY THE PATIENT. FURTHER INFORMATION REQUESTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 20872773 ↗
MalfunctionDec 6, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT A DIAM. B.S. PREP. CONIC. FG M 010 BUR BROKE DURING USE. THE USER DOES NOT KNOW WHAT HAPPENED TO THE BROKEN PART. IT IS ASSUMED THAT THEY MAY HAVE BEEN SWALLOWED. FURTHER INFORMATION REQUESTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 20872696 ↗
MalfunctionDec 6, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT A DIAM. B.S. PREP. CONIC. FG M 010 BUR BROKE DURING USE. THE USER DOES NOT KNOW WHAT HAPPENED TO THE BROKEN PART. IT IS ASSUMED THAT THEY MAY HAVE BEEN SWALLOWED. FURTHER INFORMATION REQUESTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 20871579 ↗

Device details

UDI-DI	`J003F0167342010001`
Brand	Diamond burs
Model	F016734201000
Company	MAILLEFER INSTRUMENTS HOLDING Sàrl
Product code	DZP · INSTRUMENT, DIAMOND, DENTAL
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	Not in Commercial Distribution
Record updated	Jun 6, 2025

Device type (GMDN): Diamond dental bur, reusable

A rotary cutting device made of high-grade steel with the working end coated with particles of diamond, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

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All INSTRUMENT, DIAMOND, DENTAL 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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