Cleared Traditional

K901037 - VISIONER 21-A (FDA 510(k) Clearance)

Class I Dental device.

K901037 · J. Morita USA, Inc. · Dental device
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Aug 1990
Decision
161d
Days
Class 1
Risk

K901037 is an FDA 510(k) clearance for the VISIONER 21-A. Classified as File, Pulp Canal, Endodontic (product code EKS), Class I - General Controls.

Submitted by J. Morita USA, Inc. (Irvine, US). The FDA issued a Cleared decision on August 14, 1990 after a review of 161 days - an extended review 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: 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 J. Morita USA, Inc. devices

Submission Details

510(k) Number K901037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1990
Decision Date August 14, 1990
Days to Decision 161 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 127d · This submission: 161d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EKS File, Pulp Canal, Endodontic
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.