Duns Number:318034329
Device Description: Screw for fixation of bone segments e.g. for horizontal or vertical augmentative graftsLen Screw for fixation of bone segments e.g. for horizontal or vertical augmentative graftsLength 10mm, diameter 1.1mm, core diameter 0.9mmThe bone screws have a self-tapping design and the connection between screw and screw driver is realized by a socket head or a hexalobular connection to obtain a clamping force.Dental Bone Screws are delivered non sterile.
Catalog Number
TCT09 010
Brand Name
Screw TX, dental
Version/Model Number
TCT09 010
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
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
K132212,K132212,K132212
Product Code
DZL
Product Code Name
Screw, Fixation, Intraosseous
Public Device Record Key
cae1872c-5509-4b53-8deb-6f28390001e5
Public Version Date
February 15, 2019
Public Version Number
4
DI Record Publish Date
July 10, 2015
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 | 4140 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 237 |