Duns Number:060272465
Device Description: DNTK ULTIMATE 1CT DNTL GRD 12
Catalog Number
-
Brand Name
Dentek
Version/Model Number
10047701000400A
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)
-
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
b44eacc5-38a0-41f3-88e7-e5b1cd606710
Public Version Date
July 22, 2020
Public Version Number
1
DI Record Publish Date
July 14, 2020
Package DI Number
10047701000400
Quantity per Package
1
Contains DI Package
00047701000403
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 |