K7 Evaluation System-CMS

FDA UDI

Class I (US FDA UDI)

by Myotronics-Noromed, Inc.

Identity

Trade Name: K7 Evaluation System-CMS FDA UDI
Generic Name: Jaw physiology evaluation system FDA UDI
Device Name: Multiple sensors in an extremely light weight (four ounce) spectacle-like array, track the motion of a tiny magnet attached to the lower incisal gingiva with adhesive material. The configuration is totally non-invasive and, unlike clutches, does not interfere with patient function. The opposing sensors are wide apart permitting unobstructed access to the oral cavity for taking bite registrations and other clinical procedures, and the system is virtually immune from effects of slight head motion or nearby metallic or electronic interference. A patient education mode is included to simplify patient understanding and staff training. FDA UDI
Model / Reference: K7/CMS FDA UDI
Description: Multiple sensors in an extremely light weight (four ounce) spectacle-like array, track the motion of a tiny magnet attached to the lower incisal gingiva with adhesive material. The configuration is totally non-invasive and, unlike clutches, does not interfere with patient function. The opposing sensors are wide apart permitting unobstructed access to the oral cavity for taking bite registrations and other clinical procedures, and the system is virtually immune from effects of slight head motion or nearby metallic or electronic interference. A patient education mode is included to simplify patient understanding and staff training. FDA UDI

Identifiers

Primary DI / UDI-DI: D79209940 FDA UDI
FDA Product Code: NFS FDA UDI
IKN FDA UDI
KZM FDA UDI
GMDN Term: Jaw physiology evaluation system FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.2060 FDA UDI
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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Jaw physiology evaluation system

K7 Evaluation System-CMS by Myotronics-Noromed, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Myotronics-Noromed, Inc.

Sources (1)

FDA UDI 61577118-6084-44e2-825e-5de45e14039c 34 fields · synced May 30, 2026