Cleared Traditional

Opus Bulk Fill APS, Opus Bulk Fill Flow APS (K190758) - FDA 510(k) Clearance

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

K190758 · Dentscare Ltda · Dental device
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Sep 2019
Decision
163d
Days
Class 2
Risk

K190758 is an FDA 510(k) clearance for the Opus Bulk Fill APS, Opus Bulk Fill Flow APS. 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 September 4, 2019 after a review of 163 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 K190758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2019
Decision Date September 04, 2019
Days to Decision 163 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
36d slower than avg
Panel avg: 127d · This submission: 163d
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 K190758.
CLEARFIL MAJESTY ES Flow
K191980 · Kuraray Noritake Dental, Inc. · Nov 2019
BRILLIANT COMPONEER
K191385 · Coltene/Whaledent AG · Oct 2019
Infinix Universal Composite
K182921 · Nobio , Ltd. · Sep 2019
Novidia Bulk Fill Flow Composite
K182714 · Nobio , Ltd. · Jul 2019
Novidia Flowable Composite
K182580 · Nobio , Ltd. · Jul 2019
XP Composite
K182780 · S&C Polymer Silicon- Und Composite Spezialitaeten GmbH · Jul 2019