LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES TURBO+ PR— 510(k) K141221

Clearance details

Applicant

Lares Research, Inc.

Product code

Code EFB

Device class

Class 1

Regulation

21 CFR 872.4200

Advisory panel

Dental

Date received

2014-05-12

Decision date

2014-10-28

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Chico, CA, US

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• K031540 — APEX ELECTRIC HANDPIECE SYSTEM2003-06-30
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• K961163 — LARES RESEARCH AS-1 LOWSPEED HANDPIECE1996-04-23
• K905542 — LARES APOLLO CS AND S HANDPIECE LIGHTING SYSTEMS1991-03-11

Injury

133

Malfunction

562

Total

695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →