Duns Number:564251911
Device Description: Rights of use Zirkonzahn.Implant-Planner Practice The conclusion of the Zirkonzahn.Implant Rights of use Zirkonzahn.Implant-Planner Practice The conclusion of the Zirkonzahn.Implant-Planner Practice service contract is obligatory for the duration of 12 months!Rights of use for Helpdesk customer support and automatic software updates for Zirkonzahn.Implant-Planner Practice
Catalog Number
-
Brand Name
ZIRKONZAHN.Implant-Planner Practice
Version/Model Number
SY1620
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
K203765
Product Code
LLZ
Product Code Name
System, image processing, radiological
Public Device Record Key
ef0e7d54-b0fb-43d5-9d99-1f197c87abf0
Public Version Date
September 30, 2021
Public Version Number
1
DI Record Publish Date
September 22, 2021
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 | 1369 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4845 |
| U | Unclassified | 3 |