Cleared Traditional

K201684 - A-Silicone for Bite Registration

K201684 is an FDA 510(k) clearance for A-Silicone for Bite Registration, manufactured by Shandong Huge Dental Material Corporation. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K201684 · Shandong Huge Dental Material Corporation · Dental device
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Sep 2020
Decision
94d
Days
Class 2
Risk

K201684 is an FDA 510(k) clearance for the A-Silicone for Bite Registration. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Shandong Huge Dental Material Corporation (Rizhao City, CN). The FDA issued a Cleared decision on September 24, 2020 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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

FDA 510(k) Submission Details - K201684

510(k) Number K201684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2020
Decision Date September 24, 2020
Days to Decision 94 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
33d faster than avg
Panel avg: 127d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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 - ELW Material, Impression

All 195
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K201684.
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K190571 · Dreve Dentamid GmbH · Nov 2019