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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 128d · 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 Consultant

Emergo Group
Carrie Hetrick

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 293
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K143265.
DENTCA DENTURE BASE
K143033 · Dentca, Inc. · Jul 2015
Coating Material
K150511 · Sun Medical Co., Ltd. · May 2015
Acryfree Denture Base Material and Biosens Denture Base Material
K150454 · Perflex · May 2015
TCS Blend
K142894 · Thermoplastic Comfort Systems, Inc. · Feb 2015
Ufi Gel hard C
K143486 · Voco GmbH · Jan 2015
M-PM-DISC (PINK)
K140758 · Merz Dental GmbH · Sep 2014
K143265 · Acrylic Block
Download PDF FDA Summary Sun Medical Co., Ltd.