Cleared Traditional

K140074 - HYGEDENT ALGINATE IMPRESSION MATERIAL

K140074 is an FDA 510(k) clearance for HYGEDENT ALGINATE IMPRESSION MATERIAL, manufactured by Hygedent, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K140074 · Hygedent, Inc. · Dental device
Download Printable Device Report (PDF)
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May 2014
Decision
128d
Days
Class 2
Risk

K140074 is an FDA 510(k) clearance for the HYGEDENT ALGINATE IMPRESSION MATERIAL. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Hygedent, Inc. (Guangzhou, Guangdong, CN). The FDA issued a Cleared decision on May 21, 2014 after a review of 128 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 Hygedent, Inc. devices

FDA 510(k) Submission Details - K140074

510(k) Number K140074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2014
Decision Date May 21, 2014
Days to Decision 128 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 127d · This submission: 128d
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 200
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K140074.
Hyflex Heavy, Hyflex Mono, Hyflex Light
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