Duns Number:185497372
Device Description: NuSmile Signature Anterior Replacement Crown - Central, Size 4 - Short Length / Light Shad NuSmile Signature Anterior Replacement Crown - Central, Size 4 - Short Length / Light Shade
Catalog Number
-
Brand Name
NuSmile Signature Anterior Replacement Crown
Version/Model Number
A4105LS
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
ELZ
Product Code Name
Crown, Preformed
Public Device Record Key
7d829329-75d6-4bad-84ae-6b033fcd09d4
Public Version Date
September 08, 2021
Public Version Number
1
DI Record Publish Date
August 31, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1091 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |
| U | Unclassified | 1 |