Cleared Traditional

K082927 - BIOEMG III (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K082927 · Bio-Research Associates, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
128d
Days
Class 2
Risk

K082927 is an FDA 510(k) clearance for the BIOEMG III. Classified as Device, Muscle Monitoring (product code KZM), Class II - Special Controls.

Submitted by Bio-Research Associates, Inc. (Brown Deer, US). The FDA issued a Cleared decision on February 6, 2009 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 890.1375 - 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 Bio-Research Associates, Inc. devices

Submission Details

510(k) Number K082927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2008
Decision Date February 06, 2009
Days to Decision 128 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
1d slower than avg
Panel avg: 127d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KZM Device, Muscle Monitoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1375
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.