Cleared Traditional

K152270 - Denture base resin

K152270 is an FDA 510(k) clearance for Denture base resin, manufactured by Korea Engineering Plastics Co., Ltd.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K152270 · Korea Engineering Plastics Co., Ltd. · Dental device
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Nov 2015
Decision
94d
Days
Class 2
Risk

K152270 is an FDA 510(k) clearance for the Denture base resin. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Korea Engineering Plastics Co., Ltd. (Gunpo-Si, KR). The FDA issued a Cleared decision on November 13, 2015 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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 Korea Engineering Plastics Co., Ltd. devices

FDA 510(k) Submission Details - K152270

510(k) Number K152270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2015
Decision Date November 13, 2015
Days to Decision 94 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
33d faster than avg
Panel avg: 127d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 176
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K152270.
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Ufi Gel hard C
K143486 · Voco GmbH · Jan 2015
ORTHODONTIC ACRYLIC (NOT FINALIZED)
K141439 · Bisco, Inc. · Sep 2014