Cleared Traditional

K153285 - EMS-200

K153285 is an FDA 510(k) clearance for EMS-200, manufactured by Meta Systems Co., Ltd.. The device is a Class 1 Dental device with product code EKX cleared through the Traditional 510(k) pathway after a 274-day FDA review.

K153285 · Meta Systems Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
274d
Days
Class 1
Risk

K153285 is an FDA 510(k) clearance for the EMS-200. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by Meta Systems Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on August 12, 2016 after a review of 274 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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 Meta Systems Co., Ltd. devices

FDA 510(k) Submission Details - K153285

510(k) Number K153285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2015
Decision Date August 12, 2016
Days to Decision 274 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
147d slower than avg
Panel avg: 127d · This submission: 274d
Pathway characteristics
Predicate-based equivalence.

EKX Device Classification - Class 1, General Controls

Product Code EKX Handpiece, Direct Drive, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
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 - EKX Handpiece, Direct Drive, Ac-powered

All 46
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