Duns Number:315731711
Device Description: 3M™ ESPE™ RelyX™ Unicem 2 Automix Self Adhesive Resin Cement Starter Kit, 56850. Steriliza 3M™ ESPE™ RelyX™ Unicem 2 Automix Self Adhesive Resin Cement Starter Kit, 56850. Sterilization prior to use only for RelyX Fiber Post Drills. Do not sterilize either RelyX Unicem 2 Automix nor RelyX Fiber Posts.
Catalog Number
56850
Brand Name
RelyX™ Unicem 2 Automix
Version/Model Number
56850
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
DZA
Product Code Name
DRILL, DENTAL, INTRAORAL
Public Device Record Key
bf10f824-dbc8-4ae5-9b1b-4ba24a1e838b
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 |