Cleared Abbreviated

DENU Composite Resin, DENU Flow Resin (K213339) - FDA 510(k) Clearance

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K213339 · Hdi, Inc. · Dental device
Download Printable Device Report (PDF)
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Sep 2022
Decision
351d
Days
Class 2
Risk

K213339 is an FDA 510(k) clearance for the DENU Composite Resin, DENU Flow Resin. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Hdi, Inc. (Seongnam-Si, KR). The FDA issued a Cleared decision on September 23, 2022 after a review of 351 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Hdi, Inc. devices

Submission Details

510(k) Number K213339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2021
Decision Date September 23, 2022
Days to Decision 351 days
Submission Type Abbreviated
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
224d slower than avg
Panel avg: 127d · This submission: 351d
Pathway characteristics
Standards-based clearance path.

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 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 K213339.
Stela Capsule System
K222583 · Sdi Limited · Oct 2022
TrusFIL-Flow Flowable Composite Restorative
K221510 · Rizhao Huge Biomaterials Company, Ltd. · Oct 2022
Renamel® Microhybrid
K222435 · Cosmedent, Inc. · Oct 2022
FREEPRINT crown
K222877 · Detax GmbH · Sep 2022
AMBARINO High-Class
K222723 · Creamed GmbH & Co. Produktions- Und Handels KG · Sep 2022
SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow
K221255 · Kerr Corporation · Aug 2022