Cleared Traditional

OBTURATION GUTTA (K822464) - FDA 510(k) Clearance

Class I Dental device.

K822464 · U.S. Shizai Corp. · Dental device
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Nov 1982
Decision
79d
Days
Class 1
Risk

K822464 is an FDA 510(k) clearance for the OBTURATION GUTTA. Classified as File, Margin Finishing, Operative (product code EKA), Class I - General Controls.

Submitted by U.S. Shizai Corp. (Walker, US). The FDA issued a Cleared decision on November 3, 1982 after a review of 79 days - a notably fast clearance cycle.

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: 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 K822464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1982
Decision Date November 03, 1982
Days to Decision 79 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 127d · This submission: 79d
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.