Cleared Traditional

K201683 - PMMA Block

K201683 is the FDA 510(k) clearance for PMMA Block by Huge Dental Material Co., Ltd.. It is a Class 2 Dental device (product code EBG) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K201683 · Huge Dental Material Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2020
Decision
134d
Days
Class 2
Risk

K201683 is an FDA 510(k) clearance for the PMMA Block. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Huge Dental Material Co., Ltd. (Rizhao City, CN). The FDA issued a Cleared decision on November 3, 2020 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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 Huge Dental Material Co., Ltd. devices

Submission Details

510(k) Number K201683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2020
Decision Date November 03, 2020
Days to Decision 134 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
7d slower than avg
Panel avg: 127d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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 - EBG Crown And Bridge, Temporary, Resin

All 91
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K201683.
PuRE PMMA Disc
K201563 · Quest Dental USA Corp. · Apr 2021
Aidite PMMA
K190217 · Aidite (Qinhuangdao) Technology Co., Ltd. · Dec 2020
GR-17 Resin System
K201827 · Pro3dure Medical GmbH · Nov 2020
FREEPRINT temp
K200273 · Detax GmbH & Co. KG · Oct 2020
Structur CAD
K201090 · Voco GmbH · Sep 2020
Bright Temporary C&B
K192830 · Dmp Dental Industry S.A. · Sep 2020