Duns Number:315731711
Device Description: 3M™ ESPE™ RelyX™ Unicem 2 Automix Self-Adhesive Resin Cement Translucent Shade Refill, 568 3M™ ESPE™ RelyX™ Unicem 2 Automix Self-Adhesive Resin Cement Translucent Shade Refill, 56848
Catalog Number
56848
Brand Name
RelyX™ Unicem 2 Automix
Version/Model Number
56848
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
EID
Product Code Name
SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL
Public Device Record Key
943050b8-38d1-4817-9d6f-40e388a14dd9
Public Version Date
August 21, 2019
Public Version Number
6
DI Record Publish Date
September 24, 2016
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 | 232 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 563 |
| U | Unclassified | 3 |