Duns Number:636239584
Device Description: Straumann® Zygomatic Implant, ZAGA™ Flat Ø 4.3mm, L 57.5mm, Ti
Catalog Number
CH-ZC-57.5
Brand Name
ZAGA™
Version/Model Number
CH-ZC-57.5
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
Yes
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
K192651
Product Code
DZE
Product Code Name
Implant, Endosseous, Root-Form
Public Device Record Key
80d38f26-85bb-4804-ba64-351503b12d53
Public Version Date
September 06, 2022
Public Version Number
2
DI Record Publish Date
November 23, 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 | 1050 |
2 | A medical device with a moderate to high risk that requires special controls. | 1479 |