Cleared Traditional

K260376 - Denture Base

K260376 is the FDA 510(k) clearance for Denture Base by Shandong Huge Dental Material Corporation. It is a Class 2 Dental device (product code EBI) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K260376 · Shandong Huge Dental Material Corporation · Dental device
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May 2026
Decision
90d
Days
Class 2
Risk

K260376 is an FDA 510(k) clearance for the Denture Base. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Shandong Huge Dental Material Corporation (Rizhao City, CN). The FDA issued a Cleared decision on May 6, 2026 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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 Shandong Huge Dental Material Corporation devices

Submission Details

510(k) Number K260376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2026
Decision Date May 06, 2026
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 140
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K260376.
DB 4000 High Impact Denture Base
K260569 · Carbon, Inc. · Jun 2026
LuxCreo Flexible Partial Denture Resin
K253365 · LuxCreo, Inc. · Nov 2025
TERA HARZ Hard Denture (THD-C-500)
K253681 · Graphy, Inc. · Nov 2025
UltraPrint-Dental Denture UV
K253324 · Guangzhou Heygears IMC., Inc. · Nov 2025
Freeprint® denture flex
K252430 · Detax GmbH · Oct 2025
DENTURE SOFT EX (Pink set)
K252035 · Kamemizu Chemical Industry Co., Ltd. · Sep 2025