Cleared Traditional

K130158 - M-SCAN

K130158 is an FDA 510(k) clearance for M-SCAN, manufactured by Bio-Research Associates, Inc.. The device is a Class 2 Dental device with product code KZM cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K130158 · Bio-Research Associates, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
183d
Days
Class 2
Risk

K130158 is an FDA 510(k) clearance for the M-SCAN. 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 July 25, 2013 after a review of 183 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K130158

510(k) Number K130158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2013
Decision Date July 25, 2013
Days to Decision 183 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 128d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KZM Device Classification - Class 2, Special Controls

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.

Regulatory Peers - KZM Device, Muscle Monitoring

All 18
Devices cleared under the same product code (KZM) and FDA review panel - the closest regulatory comparables to K130158.
TEETHAN 2.0
K161716 · Bts S.P.A. · Dec 2016
GRINDCARE MEASURE
K113677 · Medotech A/S · Apr 2012
BIOEMG III
K082927 · Bio-Research Associates, Inc. · Feb 2009
DOLOTENS DENTAL TM 1
K043373 · Neuromuscular Technologies, Inc. · Sep 2005
BITESTRIP
K030869 · S.L.P. , Ltd. · May 2004
BIOEMG II AND BIOJVA
K003176 · Bio-Research Associates, Inc. · Jan 2001
K130158 · M-SCAN
Download PDF FDA Summary Bio-Research Associat…