Cleared Traditional

K132315 - ERGONOMIC PRODUCTS WORKSTATION (FDA 510(k) Clearance)

Class I Dental device.

K132315 · Ergonomic Products, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
267d
Days
Class 1
Risk

K132315 is an FDA 510(k) clearance for the ERGONOMIC PRODUCTS WORKSTATION. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Ergonomic Products, Inc. (Woonsocket, US). The FDA issued a Cleared decision on April 18, 2014 after a review of 267 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 Ergonomic Products, Inc. devices

Submission Details

510(k) Number K132315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2013
Decision Date April 18, 2014
Days to Decision 267 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
140d slower than avg
Panel avg: 127d · This submission: 267d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.

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