Cleared Traditional

K901037 - VISIONER 21-A

K901037 is an FDA 510(k) clearance for VISIONER 21-A, manufactured by J. Morita USA, Inc.. The device is a Class 1 Dental device with product code EKS cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K901037 · J. Morita USA, Inc. · Dental device
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Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K901037

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 128d · This submission: 161d
Pathway characteristics
Predicate-based equivalence.

EKS Device Classification - Class 1, General Controls

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.

Regulatory Peers - EKS File, Pulp Canal, Endodontic

All 30
Devices cleared under the same product code (EKS) and FDA review panel - the closest regulatory comparables to K901037.
DENTAURUM CERAMIC DEBONDING UNIT
K902018 · Dentauraum, Inc. · Apr 1991
PROCEDURE KIT/ROUTINE DENTAL PROCEDURES
K905461 · Angiosystems, Inc. · Mar 1991
SOLID CORE GUTTA PERCHA CARRIER
K905640 · The Hygenic Corp. · Mar 1991
A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD)
K897195 · A Company, Inc. · May 1990
DE-BOND 200
K883418 · Scheu-Dental · Oct 1989
DENTAL PIK
K892861 · U.S. Dentek Corp. · Sep 1989
K901037 · VISIONER 21-A
Download PDF J. Morita USA, Inc.