Who else makes this device?

Name: Teethan
Brand: Teethan

Physical Medicine › DiagnosticDevice, Muscle Monitoring

Teethan

Indication for use: To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter To clinically monitor 2 different muscles as an aid in the…

Registry build 21.09.26

Indication for use: To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter To clinically monitor 2 different muscles as an aid in the diagnosis and treatment evaluation by recording the electrical activity of muscles of the stomatognathic system To measure relative (intra-patient) levels of activity of 2 muscles during a functional act

1manufacturer

1catalogue number

Who Else Makes It

Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code KZM
Manufacturer	City	Province	Registered as	Device types
Jiangyin Sinbon Electronics Co Ltd	Jiangyin	Jiangsu	Contract manufacturer	13

Record

Regulatory record for Teethan
Listed by	BTS SPA, Italy
FDA product code	KZM
Device type	Device, Muscle Monitoring
Device class	Class 2
Regulation	21 CFR 890.1375
Establishment	Manufacturer
510(k)	K161716
Record published	2017-09-26
Record revised	2022-11-28 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	serial number
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Teethan
Catalogue number	Size	Status
2.0		In distribution

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Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.