Cleared Traditional

K221510 - TrusFIL-Flow Flowable Composite Restorative

K221510 is an FDA 510(k) clearance for TrusFIL-Flow Flowable Composite Restorative, manufactured by Rizhao Huge Biomaterials Company, Ltd.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K221510 · Rizhao Huge Biomaterials Company, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2022
Decision
141d
Days
Class 2
Risk

K221510 is an FDA 510(k) clearance for the TrusFIL-Flow Flowable Composite Restorative. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Rizhao Huge Biomaterials Company, Ltd. (Rizhao City, CN). The FDA issued a Cleared decision on October 12, 2022 after a review of 141 days - within the typical 510(k) review window.

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 Rizhao Huge Biomaterials Company, Ltd. devices

FDA 510(k) Submission Details - K221510

510(k) Number K221510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2022
Decision Date October 12, 2022
Days to Decision 141 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
14d slower than avg
Panel avg: 127d · This submission: 141d
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 Peers - EBF Material, Tooth Shade, Resin

All 645
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K221510.
Premier's MultiMatch Universal Chameleon Restorative Composite
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DENU Composite Resin, DENU Flow Resin
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K222877 · Detax GmbH · Sep 2022