Duns Number:081472844
Device Description: ZGO Tapered Pilot Drills are used to create the initial hole in bone to prepare an osteoto ZGO Tapered Pilot Drills are used to create the initial hole in bone to prepare an osteotomy for zygomatic implant placement and monitor the drilling depth.
Catalog Number
-
Brand Name
2.0mm ZGO Tapered Pilot Drill 65mm length
Version/Model Number
ZPLTT-65
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
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
-
Product Code
EJL
Product Code Name
Bur, Dental
Public Device Record Key
9f776f60-dc9e-4d3c-8ea7-94a3747f4ac1
Public Version Date
July 07, 2022
Public Version Number
1
DI Record Publish Date
June 29, 2022
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 | 72 |