Duns Number:459034567
Device Description: SUPER LUX A1-D4 , SIX ARTIFICIAL TEETH, UPPER, SHADE B2, MOULD 1/49
Catalog Number
T3011
Brand Name
SUPER LUX A1-D4 X6 UPPER B2-1/49
Version/Model Number
Shade B2, Mould 1/49
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
Yes
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
ELM
Product Code Name
Denture, Plastic, Teeth
Public Device Record Key
b33032a7-c788-4ed6-a6df-1fd2ec6e5fa2
Public Version Date
September 17, 2019
Public Version Number
1
DI Record Publish Date
September 09, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2205 |