K7 CMS Sensor Array 0996

GUDID D79209960

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.

MYOTRONICS NOROMED, INC

Jaw physiology evaluation system

• Primary Device ID: D79209960
• NIH Device Record Key: c1050b7e-2253-4929-a262-08d0f7c43e6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K7 CMS Sensor Array
• Version Model Number: K7 CMS Sensor Array
• Catalog Number: 0996
• Company DUNS: 053824652
• Company Name: MYOTRONICS NOROMED, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 2062434214
• Email: info@myotronics.com
• Phone: 2062434214
• Email: info@myotronics.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D79209960 [Primary]

FDA Product Code

• NFS: Device, Jaw Tracking, For Monitoring Jaw Positions

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-18

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