Cleared Traditional

K133071 - ELASTIC IMPRESSION MATERIAL

K133071 is an FDA 510(k) clearance for ELASTIC IMPRESSION MATERIAL, manufactured by Rizhao Huge Dental Industry Co., Ltd.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K133071 · Rizhao Huge Dental Industry Co., Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
240d
Days
Class 2
Risk

K133071 is an FDA 510(k) clearance for the ELASTIC IMPRESSION MATERIAL. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Rizhao Huge Dental Industry Co., Ltd. (Dover, US). The FDA issued a Cleared decision on May 28, 2014 after a review of 240 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K133071

510(k) Number K133071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2013
Decision Date May 28, 2014
Days to Decision 240 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
112d slower than avg
Panel avg: 128d · This submission: 240d
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 364
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K133071.
VONFLEX S BITE
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K140602 · 3M Espe AG · Jun 2014
HYGEDENT ALGINATE IMPRESSION MATERIAL
K140074 · Hygedent, Inc. · May 2014
MD-FLEX HEAVY BODY
K134008 · Meta Biomed, Inc. · Apr 2014
FLASH AR
K133436 · 3M Deutschland GmbH · Mar 2014