Cleared Traditional

K133298 - ENDO SMART (FDA 510(k) Clearance)

Class I Dental device.

K133298 · Meta Biomed, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
329d
Days
Class 1
Risk

K133298 is an FDA 510(k) clearance for the ENDO SMART. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by Meta Biomed, Inc. (Mt. Airy, US). The FDA issued a Cleared decision on September 19, 2014 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Biomed, Inc. devices

Submission Details

510(k) Number K133298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2013
Decision Date September 19, 2014
Days to Decision 329 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
202d slower than avg
Panel avg: 127d · This submission: 329d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 88
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