Cleared Traditional

Omnichroma Flow Bulk (K203598) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K203598 · Tokuyama Dental Corporation · Dental device
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Optimized for regulatory review, auditing and printing
Feb 2021
Decision
56d
Days
Class 2
Risk

K203598 is an FDA 510(k) clearance for the Omnichroma Flow Bulk. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Tokuyama Dental Corporation (Taitou-Ku, JP). The FDA issued a Cleared decision on February 3, 2021 after a review of 56 days - a notably fast clearance 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: 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 Tokuyama Dental Corporation devices

Submission Details

510(k) Number K203598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2020
Decision Date February 03, 2021
Days to Decision 56 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
71d faster than avg
Panel avg: 127d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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. Baritt

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 291
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K203598.
Renamel Bulkfill
K211259 · Cosmedent, Inc. · Jun 2021
E-Dent 1000
K210977 · Envisiontec GmbH · May 2021
Shofu Block HC Hard
K200470 · Shofu Dental Corporation · Feb 2021
Opallis, Opallis Flow
K201707 · Dentscare Ltda · Dec 2020
Bright High Flow
K200155 · Genoss Co., Ltd. · Nov 2020
Bright Low Flow
K200156 · Genoss Co., Ltd. · Oct 2020