Duns Number:021228671
Device Description: Device to alleviate pain caused by bruxing or clenching of teeth
Catalog Number
COMSPL
Brand Name
Comfort Splint
Version/Model Number
COMSPL
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K121365
Product Code
MQC
Product Code Name
Mouthguard, prescription
Public Device Record Key
18ee733a-abae-465e-92f2-db795ac12a7a
Public Version Date
December 21, 2020
Public Version Number
2
DI Record Publish Date
September 23, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 510 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2971 |
| U | Unclassified | 2 |