Cleared Traditional

K133298 - ENDO SMART

K133298 is an FDA 510(k) clearance for ENDO SMART, manufactured by Meta Biomed, Inc.. The device is a Class 1 Dental device with product code EKX cleared through the Traditional 510(k) pathway after a 329-day FDA review.

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

FDA 510(k) Submission Details - K133298

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.

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 57
Devices cleared under the same product code (EKX) and FDA review panel - the closest regulatory comparables to K133298.
TRAUS ENDO
K143411 · Saeshin Precision Co., Ltd. · Jun 2015
AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION)
K150129 · Aseptico, Inc. · May 2015
AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM
K142124 · Aseptico, Inc. · Dec 2014
IPROPHY MOBILE
K131578 · Nakanishi, Inc. · Sep 2013
TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE
K112665 · J. Morita USA, Inc. · May 2012
CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900
K110278 · Nakanishi, Inc. · Feb 2012