Cleared Abbreviated

K141421 - PMMA BLOCK

K141421 is an FDA 510(k) clearance for PMMA BLOCK, manufactured by Rizhao Huge Dental Industry Co., Ltd.. The device is a Class 2 Dental device with product code EBG cleared through the Abbreviated 510(k) pathway after a 255-day FDA review.

K141421 · Rizhao Huge Dental Industry Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
255d
Days
Class 2
Risk

K141421 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 Rizhao Huge Dental Industry Co., Ltd. (Wenzhou, Zhejiang, CN). The FDA issued a Cleared decision on February 9, 2015 after a review of 255 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Rizhao Huge Dental Industry Co., Ltd. devices

FDA 510(k) Submission Details - K141421

510(k) Number K141421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2014
Decision Date February 09, 2015
Days to Decision 255 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
128d slower than avg
Panel avg: 127d · This submission: 255d
Pathway characteristics
Standards-based clearance path.

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 118
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