Cleared Traditional

K842358 - ISOLIGHT (FDA 510(k) Clearance)

Class I Dental device.

K842358 · Planmeca USA, Inc. · Dental device
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Jul 1984
Decision
39d
Days
Class 1
Risk

K842358 is an FDA 510(k) clearance for the ISOLIGHT. Classified as Light, Surgical Headlight (product code EBA), Class I - General Controls.

Submitted by Planmeca USA, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 31, 1984 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4630 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Planmeca USA, Inc. devices

Submission Details

510(k) Number K842358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1984
Decision Date July 31, 1984
Days to Decision 39 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 127d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EBA Light, Surgical Headlight
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4630
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.