Cleared Traditional

K202063 - TrusFIL Universal Composite Restorative (FDA 510(k) Clearance)

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

K202063 · Rizhao Huge Biomaterials Company, Ltd. · Dental device
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Oct 2021
Decision
436d
Days
Class 2
Risk

K202063 is an FDA 510(k) clearance for the TrusFIL Universal 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 6, 2021 after a review of 436 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Rizhao Huge Biomaterials Company, Ltd. devices

Submission Details

510(k) Number K202063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2020
Decision Date October 06, 2021
Days to Decision 436 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
309d slower than avg
Panel avg: 127d · This submission: 436d
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 Peers - EBF Material, Tooth Shade, Resin

All 926
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