Cleared Traditional

K201683 - PMMA Block

K201683 is an FDA 510(k) clearance for PMMA Block, manufactured by Huge Dental Material Co., Ltd.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K201683

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.

EBG Device Classification - Class 2, Special Controls

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 150
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