Cleared Traditional

K850294 - CANAL FINDER

K850294 is an FDA 510(k) clearance for CANAL FINDER, manufactured by Roseburg SA. The device is a Class 1 Dental device with product code EGS cleared through the Traditional 510(k) pathway after a 131-day FDA review.

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

FDA 510(k) Submission Details - K850294

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 127d · This submission: 131d
Pathway characteristics
Predicate-based equivalence.

EGS Device Classification - Class 1, General Controls

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.