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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 128d · 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 Consultant

International Regulatory Consultants
CHARLIE MACK

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EBI Resin, Denture, Relining, Repairing, Rebasing

All 290
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K152270.
AvaDent Denture Base Material
K153590 · Global Dental Science · Apr 2016
ClearMet
K152051 · Mycone Dental Supply Co., T/A Keystone Industries · Mar 2016
GC Reline II
K153253 · GC America, Inc. · Mar 2016
ProTech Plus
K151646 · Protech Professional Products, Inc. · Oct 2015
IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID
K151142 · Wieland Dental + Technik GmbH & Co. KG · Aug 2015
DENTCA DENTURE BASE
K143033 · Dentca, Inc. · Jul 2015