Duns Number:462114760
Device Description: IDODENTINE DISC PINK + MULTI B1 98,5/25mm
Catalog Number
P425/B1
Brand Name
IDODENTINE
Version/Model Number
DISC MULTI PINK-B1 98,5/25mm
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K150432
Product Code
EBG
Product Code Name
Crown And Bridge, Temporary, Resin
Public Device Record Key
5775c10f-c900-4541-817d-4f629008ffa3
Public Version Date
October 29, 2021
Public Version Number
2
DI Record Publish Date
July 09, 2018
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. | 1566 |