Cleared Traditional

K143265 - Acrylic Block

K143265 is an FDA 510(k) clearance for Acrylic Block, manufactured by Sun Medical Co., Ltd.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K143265 · Sun Medical Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
152d
Days
Class 2
Risk

K143265 is an FDA 510(k) clearance for the Acrylic Block. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Sun Medical Co., Ltd. (Moriyama, JP). The FDA issued a Cleared decision on April 14, 2015 after a review of 152 days - an extended review cycle.

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 Sun Medical Co., Ltd. devices

FDA 510(k) Submission Details - K143265

510(k) Number K143265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2014
Decision Date April 14, 2015
Days to Decision 152 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
25d slower than avg
Panel avg: 127d · This submission: 152d
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 K143265.
Pour Acrylic
K161330 · Dentsply Sirona · Oct 2016
GC Reline II
K153253 · GC America, Inc. · Mar 2016
IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID
K151142 · Wieland Dental + Technik GmbH & Co. KG · Aug 2015
Ufi Gel hard C
K143486 · Voco GmbH · Jan 2015
ORTHODONTIC ACRYLIC (NOT FINALIZED)
K141439 · Bisco, Inc. · Sep 2014
SOFRELINER TOUGH S
K112445 · Tokuyama Dental Corporation · Oct 2011