Cleared Traditional

K172683 - Yamahachi Pink CAD/CAM Disk

K172683 is an FDA 510(k) clearance for Yamahachi Pink CAD/CAM Disk, manufactured by YAMAHACHI DENTAL MFG., Co.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 132-day FDA review.

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

FDA 510(k) Submission Details - K172683

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.

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

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 157
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