Cleared Traditional

LARES HANDPIECE OIL (K801535) - FDA 510(k) Clearance

Class I Dental device.

K801535 · Lares Manufacturing Co., Inc. · Dental device
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Dec 1980
Decision
166d
Days
Class 1
Risk

K801535 is an FDA 510(k) clearance for the LARES HANDPIECE OIL. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Lares Manufacturing Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on December 16, 1980 after a review of 166 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Lares Manufacturing Co., Inc. devices

Submission Details

510(k) Number K801535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1980
Decision Date December 16, 1980
Days to Decision 166 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 127d · This submission: 166d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFB Handpiece, Air-powered, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.