Cleared Traditional

Yamahachi Pink CAD/CAM Disk (K172683) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K172683 · YAMAHACHI DENTAL MFG., Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2018
Decision
132d
Days
Class 2
Risk

K172683 is an FDA 510(k) clearance for the Yamahachi Pink CAD/CAM Disk. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by YAMAHACHI DENTAL MFG., Co. (Gamagori, JP). The FDA issued a Cleared decision on January 16, 2018 after a review of 132 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 YAMAHACHI DENTAL MFG., Co. devices

Submission Details

510(k) Number K172683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2017
Decision Date January 16, 2018
Days to Decision 132 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
5d slower than avg
Panel avg: 127d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Denterprise International, Inc. / 510k FDA Consulting
Joyce St. Germaine

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 111
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K172683.
Lucitone Denture Base Materials
K182422 · Dentsply Sirona · Dec 2018
Juell 3D Volo Base
K181220 · Park Dental Research Corporation · Oct 2018
Keymill
K172764 · Mycone Dental Supply Company, Inc. (Aka Keystone Industries) · Apr 2018
GC Reline II
K153253 · GC America, Inc. · Mar 2016
Ufi Gel hard C
K143486 · Voco GmbH · Jan 2015
QUICK UP
K110440 · Voco GmbH · May 2011