Cleared Traditional

OBTURATION SYSTEM KIT (K820639) - FDA 510(k) Clearance

Class I Dental device.

K820639 · U.S. Shizai Corp. · Dental device
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Apr 1982
Decision
32d
Days
Class 1
Risk

K820639 is an FDA 510(k) clearance for the OBTURATION SYSTEM KIT. Classified as Gutta-percha (product code EKM), Class I - General Controls.

Submitted by U.S. Shizai Corp. (Mchenry, US). The FDA issued a Cleared decision on April 9, 1982 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3850 - 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 U.S. Shizai Corp. devices

Submission Details

510(k) Number K820639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1982
Decision Date April 09, 1982
Days to Decision 32 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 127d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EKM Gutta-percha
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3850
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.