Cleared Traditional

K151764 - YAMAHACHI PMMA DISKS

K151764 is an FDA 510(k) clearance for YAMAHACHI PMMA DISKS, manufactured by Yamahachi Dental Products USA, Inc.. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K151764 · Yamahachi Dental Products USA, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2015
Decision
146d
Days
Class 2
Risk

K151764 is an FDA 510(k) clearance for the YAMAHACHI PMMA DISKS. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Yamahachi Dental Products USA, Inc. (Nutley, US). The FDA issued a Cleared decision on November 23, 2015 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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 - K151764

510(k) Number K151764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2015
Decision Date November 23, 2015
Days to Decision 146 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
18d slower than avg
Panel avg: 128d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBG Device Classification - Class 2, Special Controls

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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.
JOHN F. GILLESPY

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 - EBG Crown And Bridge, Temporary, Resin

All 174
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K151764.
Vericore Gradient Temporary Disc
K152443 · Whip Mix Corporation · May 2016
TelioCAD Multi
K153753 · Ivoclar Vivadent, Inc. · Apr 2016
DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR
K152215 · Dentalplus GmbH · Jan 2016
SuPro 100
K151144 · 3M Deutschland GmbH · Sep 2015
IDODENTINE DISC, IDODENTINE BLOCK
K150432 · Union Dental S.A. · Aug 2015
Luminesse PMMA
K142371 · Talladium, Inc. · Apr 2015