Cleared Traditional

K830764 - FR ROOT CANAL SEALER

K830764 is an FDA 510(k) clearance for FR ROOT CANAL SEALER, manufactured by Shizai Corp.. The device is a Class 1 Dental device with product code EKA cleared through the Traditional 510(k) pathway after a 138-day FDA review.

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

FDA 510(k) Submission Details - K830764

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
10d slower than avg
Panel avg: 128d · This submission: 138d
Pathway characteristics
Predicate-based equivalence.

EKA Device Classification - Class 1, General Controls

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.