Lares Research 757 ProStyle SF SLRecalls & reported problems

Lares Research · High-speed Handpiece, 757 ProStyle SF, Swivel, Fiber optic · Class 1

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 D950131402220), received between Jul 22, 2025 and Jul 22, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

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

Most reported problems

Device problems

Device Damaged by Another Device1
Material Integrity Problem1

Patient problems

Tooth Fracture1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionJul 22, 2025Device Damaged by Another Device; Material Integrity Problem; Device Damaged by Another Device; Material Integrity Problem
DR. HAD A BUR BEND WHILE OPERATING ON PATIENT. THE TOOTH WAS CRACKED AS A RESULT OF THE BENT BUR. THE TOOTH WAS SAVED AND A CROWN WAS INSTALLED.
Patient problems: Tooth Fracture
MAUDE report 22565082 ↗

Device details

UDI-DI	`D950131402220`
Brand	Lares Research
Model	757 ProStyle SF SL
Catalog no.	13140-222
Company	Lares Research
Product code	EFB · Handpiece, Air-Powered, Dental
Class	Class 1
FDA submission	K141221
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Jun 11, 2024

Device type (GMDN): Pneumatic dental scaling/debridement system handpiece

A holder for a detachable tip that functions as part of a pneumatic dental scaling/debridement system, designed to use compressed air to generate a vibrating action at the tip to: 1) mechanically fragment and dislodge gross debris in the dental pulp canal during an endodontic procedure; and/or 2) remove accretions from tooth surfaces during dental cleaning/periodontal therapy. Water is also fed through the handpiece and attached tip to assist in the process. It is typically designed with a standard 2-, 3-, or 4-hole connector utilizing the same connection to existing air-driven handpiece tubing and the water spray for lavage. This is a reusable device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.