Duns Number:009900424
Device Description: 170gm SNAP™ Resin Shade 69
Catalog Number
S450
Brand Name
SNAP™
Version/Model Number
S450
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 10, 2021
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
-
Product Code
EBG
Product Code Name
Crown And Bridge, Temporary, Resin
Public Device Record Key
2d559f86-e25f-4186-817c-50ad24474228
Public Version Date
September 22, 2022
Public Version Number
3
DI Record Publish Date
November 02, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 36 |
2 | A medical device with a moderate to high risk that requires special controls. | 476 |
U | Unclassified | 19 |