Duns Number:094146123
Device Description: Restorative Instrumentation SystemEverything you need to restore our entire line of two-st Restorative Instrumentation SystemEverything you need to restore our entire line of two-stage implantsA system that contains all instrumentation needed to restore our entire line of two stagedental implants; including the TSI, ERI, Engage™ and Macro™. All components are labeledfor easy removal and return to the tray after autoclaving for sterilization.
Catalog Number
Restorative Kit
Brand Name
Restorative System
Version/Model Number
Restorative Instrumentation System
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EIL
Product Code Name
Gauge, Depth, Instrument, Dental
Public Device Record Key
52702d99-704f-471c-a6ae-d1a9cb0b7b8a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 21, 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 | 76 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 348 |