Duns Number:060272465
Device Description: DNTL GRD SUPERIOR CMF NO BOIL 2CT CVS 12
Catalog Number
-
Brand Name
Dentek
Version/Model Number
00015101203I2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OBR
Product Code Name
Mouthguard, Over-The-Counter
Public Device Record Key
67789d48-77b9-4a89-b6b6-396caad01755
Public Version Date
August 17, 2020
Public Version Number
1
DI Record Publish Date
August 07, 2020
Package DI Number
30050428373263
Quantity per Package
1
Contains DI Package
00050428373262
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Single
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 7 |
2 | A medical device with a moderate to high risk that requires special controls. | 6 |
U | Unclassified | 14 |