Cleared Traditional

K152100 - Evogue Dental Unit

K152100 is an FDA 510(k) clearance for Evogue Dental Unit, manufactured by Takara Belmont Corporation. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K152100 · Takara Belmont Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
178d
Days
Class 1
Risk

K152100 is an FDA 510(k) clearance for the Evogue Dental Unit. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Takara Belmont Corporation (Osaka, JP). The FDA issued a Cleared decision on January 22, 2016 after a review of 178 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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 Takara Belmont Corporation devices

FDA 510(k) Submission Details - K152100

510(k) Number K152100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2015
Decision Date January 22, 2016
Days to Decision 178 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 127d · This submission: 178d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EIA Unit, Operative Dental

All 88
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