Cleared Traditional

K905542 - LARES APOLLO CS AND S HANDPIECE LIGHTING SYSTEMS

K905542 is an FDA 510(k) clearance for LARES APOLLO CS AND S HANDPIECE LIGHTIN..., manufactured by Lares Research, Inc.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K905542 · Lares Research, Inc. · Dental device
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Mar 1991
Decision
90d
Days
Class 1
Risk

K905542 is an FDA 510(k) clearance for the LARES APOLLO CS AND S HANDPIECE LIGHTING SYSTEMS. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Lares Research, Inc. (Chico, US). The FDA issued a Cleared decision on March 11, 1991 after a review of 90 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K905542

510(k) Number K905542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1990
Decision Date March 11, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 128d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

EFB Device Classification - Class 1, General Controls

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.

Regulatory Peers - EFB Handpiece, Air-powered, Dental

All 240
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K905542.
W-H TOPAIR DENTAL HANDPIECE
K912786 · Sabra-The Dental Products Group · Jul 1991
OSTEOMED IB DRILL
K911937 · Osteomed Corp. · Jun 1991
29540 DYNASURG ELECTRIC HANDPIECE AND IRR. SYSTEM
K911068 · Micro Motors, Inc. · May 1991
LARES 757 WORKHORSE HIGHSPEED HANDPIECE
K905541 · Lares Research, Inc. · Mar 1991
HIGH SPEED CEREAMIC BEARING TURBINE HANDPIECES
K905155 · Star Dental Mfg. Co. · Feb 1991
QAR HANDPIECE
K904671 · Collagen Corp. · Dec 1990
K905542 · LARES APOLLO CS AND S HANDPIECE LIGHTING SYSTEMS
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