Cleared Traditional

FR ROOT CANAL SEALER (K830764) - FDA 510(k) Clearance

Class I Dental device.

K830764 · Shizai Corp. · Dental device
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Jul 1983
Decision
138d
Days
Class 1
Risk

K830764 is an FDA 510(k) clearance for the FR ROOT CANAL SEALER. Classified as File, Margin Finishing, Operative (product code EKA), Class I - General Controls.

Submitted by Shizai Corp. (Mchenry, US). The FDA issued a Cleared decision on July 26, 1983 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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 Shizai Corp. devices

Submission Details

510(k) Number K830764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1983
Decision Date July 26, 1983
Days to Decision 138 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 127d · This submission: 138d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EKA File, Margin Finishing, Operative
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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.