Duns Number:459034567
Device Description: SUPER LUX A1-D4 , EIGHT ARTIFICIAL TEETH, UPPER, SHADE A2, MOULD 1/74
Catalog Number
T3012
Brand Name
SUPER LUX A1-D4 X8 UPPER A2-1/74
Version/Model Number
Shade A2, Mould 1/74
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
516b9a44-14b9-41f4-be0b-a517ecb78403
Public Version Date
October 16, 2019
Public Version Number
1
DI Record Publish Date
October 08, 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 |