M-Scan

FDA UDI

Class II (US FDA UDI)

by Bio-Research Associates, Inc.

Identity

Trade Name: M-Scan FDA UDI
Generic Name: Jaw physiology evaluation system FDA UDI
Device Name: M-Scan is specifically designed to record craniofacial muscle activity during function and resting. FDA UDI
Model / Reference: Rest FDA UDI
Description: M-Scan is specifically designed to record craniofacial muscle activity during function and resting. FDA UDI

Identifiers

Primary DI / UDI-DI: 00860003499955 FDA UDI
510(k) Number: K130158 FDA UDI
FDA Product Code: KZM FDA UDI
GMDN Term: Jaw physiology evaluation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.1375 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Jaw physiology evaluation system

M-Scan by Bio-Research Associates, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K130158 also covers:

M-Scan — BIO-RESEARCH ASSOCIATES, INC.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Bio-Research Associates, Inc.

Sources (1)

FDA UDI 086b40a7-2a6b-47e8-9e32-ea8b53c6ae15 35 fields · synced Jun 8, 2026