Duns Number:830016148
Device Description: 3M™ Unitek™ Stainless Steel Crowns - Primary Anterior Set, 908100
Catalog Number
908100
Brand Name
3M™ Unitek™
Version/Model Number
908100
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)
Yes
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
9ab6d43b-2d01-45b3-a993-2f08fbcc14d5
Public Version Date
March 10, 2021
Public Version Number
2
DI Record Publish Date
September 24, 2018
Package DI Number
50605861011179
Quantity per Package
10
Contains DI Package
30605861011175
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |