Duns Number:185497372
Device Description: NuSmile Pre-Contoured Stainless Steel Crowns Second Primary Molar Posterior Evaluation Kit NuSmile Pre-Contoured Stainless Steel Crowns Second Primary Molar Posterior Evaluation Kit - 12 Crowns
Catalog Number
-
Brand Name
NuSmile Pre-Contoured Stainless Steel Crowns Second Primary Molar Posterior Eval
Version/Model Number
EKE606
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
b5d1fbf4-8c77-481a-89d4-e38531a34ccf
Public Version Date
October 03, 2022
Public Version Number
1
DI Record Publish Date
September 23, 2022
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 |