Cleared Traditional

Opallis, Opallis Flow (K201707) - FDA 510(k) Clearance

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

K201707 · Dentscare Ltda · Dental device
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Dec 2020
Decision
183d
Days
Class 2
Risk

K201707 is an FDA 510(k) clearance for the Opallis, Opallis Flow. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Dentscare Ltda (Joinville, BR). The FDA issued a Cleared decision on December 22, 2020 after a review of 183 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 Dentscare Ltda devices

Submission Details

510(k) Number K201707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2020
Decision Date December 22, 2020
Days to Decision 183 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
56d slower than avg
Panel avg: 127d · This submission: 183d
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

United Regulatory, LLC
Rodrigo Abreu

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 K201707.
E-Dent 1000
K210977 · Envisiontec GmbH · May 2021
Shofu Block HC Hard
K200470 · Shofu Dental Corporation · Feb 2021
Omnichroma Flow Bulk
K203598 · Tokuyama Dental Corporation · Feb 2021
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