Duns Number:794668751
Device Description: Temp Esthetic Disc, 95 X 20mm, Shade C1
Catalog Number
-
Brand Name
Temp Esthetic
Version/Model Number
30071-20
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
Yes
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
K102341
Product Code
EBG
Product Code Name
Crown And Bridge, Temporary, Resin
Public Device Record Key
12673620-d54f-4284-abde-693d3296c1bd
Public Version Date
October 29, 2021
Public Version Number
2
DI Record Publish Date
May 14, 2021
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. | 94 |