Duns Number:078352849
Device Description: Bone Expander Screw Kit (5). Contains 2.6, 3.0, 3.4, 3.8 and 4.3mm Expanders, Ratchet Wren Bone Expander Screw Kit (5). Contains 2.6, 3.0, 3.4, 3.8 and 4.3mm Expanders, Ratchet Wrench, Ratchet Extender, Latch Grip Adapter, Thumb Wrench, and BoxUsed to create an osteotomy for Implant placement.
Catalog Number
Bone Expander Screw Kit (5)
Brand Name
Bone Expander Screw Kit
Version/Model Number
Bone Expander Screw Kit
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
K141764
Product Code
DZN
Product Code Name
Instruments, Dental Hand
Public Device Record Key
c580c722-31a7-4962-b000-2565063cbee4
Public Version Date
May 31, 2021
Public Version Number
2
DI Record Publish Date
February 03, 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 | 405 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 536 |