Duns Number:012430880
Device Description: Self-Adhesive Resin Cement - Universal
Catalog Number
5700515
Brand Name
Henry Schein Natural Elegance
Version/Model Number
5700515
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
-
Product Code
EMA
Product Code Name
CEMENT, DENTAL
Public Device Record Key
b80ae52a-bfba-4fe0-aedc-33962f9331b6
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 28, 2017
Package DI Number
10304040040413
Quantity per Package
30
Contains DI Package
00304040040416
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3829 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 34 |