Cleared Traditional

K163568 - SHOFU RESIN GLAZE

K163568 is an FDA 510(k) clearance for SHOFU RESIN GLAZE, manufactured by Shofu Dental Corporation. The device is a Class 2 Dental device with product code EBD cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K163568 · Shofu Dental Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
240d
Days
Class 2
Risk

K163568 is an FDA 510(k) clearance for the SHOFU RESIN GLAZE. Classified as Coating, Filling Material, Resin (product code EBD), Class II - Special Controls.

Submitted by Shofu Dental Corporation (San Marcos, US). The FDA issued a Cleared decision on August 16, 2017 after a review of 240 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3310 - 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 Shofu Dental Corporation devices

FDA 510(k) Submission Details - K163568

510(k) Number K163568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2016
Decision Date August 16, 2017
Days to Decision 240 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 127d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBD Device Classification - Class 2, Special Controls

Product Code EBD Coating, Filling Material, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3310
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 - EBD Coating, Filling Material, Resin

All 38
Devices cleared under the same product code (EBD) and FDA review panel - the closest regulatory comparables to K163568.
RODIN Palette Naturalizing Kit
K223365 · Belport Company, Inc., Gingi-Pak · Mar 2023
VITA Akzent LC
K211854 · Vita Zahnfabrik GmbH H Rauter & CO · Nov 2021
Nano Varnish, Plaquit, Lightpaint on Surface
K162408 · Dreve Dentamid GmbH · Apr 2018
OPTIGLAZE COLOR
K133836 · GC America, Inc. · Mar 2014
EASY GLAZE
K082285 · Voco GmbH · Oct 2008
DURAFINISH ALL-CURE, MODEL S296
K080549 · Parkell, Inc. · May 2008