Duns Number:428484518
Device Description: Indication for use: To record electrical activity of 2 muscles of the stomatognathic syste Indication for use: To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter Toclinically monitor 2 different muscles as an aid in the diagnosis and treatment evaluation by recording the electrical activity ofmuscles of the stomatognathic system To measure relative (intra-patient) levels of activity of 2 muscles during a functional act
Catalog Number
BTSEMB1BM
Brand Name
TEETHAN
Version/Model Number
2.0
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K161716,K161716
Product Code
KZM
Product Code Name
Device, Muscle Monitoring
Public Device Record Key
a0127a34-f916-48d0-a5ba-e331b0b93b91
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 26, 2017
Package DI Number
B179THN1
Quantity per Package
1
Contains DI Package
B179THN2
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |