Cleared Traditional

K193537 - Omnichroma Flow

K193537 is an FDA 510(k) clearance for Omnichroma Flow, manufactured by Tokuyama Dental Corporation. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K193537 · Tokuyama Dental Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2020
Decision
243d
Days
Class 2
Risk

K193537 is an FDA 510(k) clearance for the Omnichroma Flow. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Tokuyama Dental Corporation (Tokyo, JP). The FDA issued a Cleared decision on August 19, 2020 after a review of 243 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 Tokuyama Dental Corporation devices

FDA 510(k) Submission Details - K193537

510(k) Number K193537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2019
Decision Date August 19, 2020
Days to Decision 243 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 127d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Consultant

Fish & Richardson, P.C.
Keith A. Barritt

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EBF Material, Tooth Shade, Resin

All 648
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K193537.
Bright High Flow
K200155 · Genoss Co., Ltd. · Nov 2020
Bright Low Flow
K200156 · Genoss Co., Ltd. · Oct 2020
Transcend
K201795 · Ultradent Product, Inc. · Sep 2020
Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite
K201010 · Nobio , Ltd. · Aug 2020
VisCalor
K201307 · Voco GmbH · Jul 2020
VarseoSmile Crown plus
K201668 · Bego Bremer Goldschl?gerei Wilh. Herbst GmbH & Co. KG · Jun 2020