Cleared Traditional

K850294 - CANAL FINDER (FDA 510(k) Clearance)

Class I Dental device.

K850294 · Roseburg SA · Dental device
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Jun 1985
Decision
131d
Days
Class 1
Risk

K850294 is an FDA 510(k) clearance for the CANAL FINDER. Classified as Handpiece, Contra- And Right-angle Attachment, Dental (product code EGS), Class I - General Controls.

Submitted by Roseburg SA (Washington, US). The FDA issued a Cleared decision on June 4, 1985 after a review of 131 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.

View all Roseburg SA devices

Submission Details

510(k) Number K850294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1985
Decision Date June 04, 1985
Days to Decision 131 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 127d · This submission: 131d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EGS Handpiece, Contra- And Right-angle Attachment, 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 - EGS Handpiece, Contra- And Right-angle Attachment, Dental

All 72
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