Duns Number:318034329
Device Description: Screw system for fixation of bone segments e.g. for horizontal or vertical augmentative gr Screw system for fixation of bone segments e.g. for horizontal or vertical augmentative graftsThe kit includes dental screws TX and neccessary accessories.The 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.The following screws are included:7pcs TCT09 007,7pcs TCT09 010,3pcs TCT10 007,3pcs TCT10 0107pcs TCT09 013,7pcs TCT09 016,3pcs TCT10 013,3pcs TCT10 016
Catalog Number
BTXPR
Brand Name
Screw System TX Professional
Version/Model Number
BTXPR
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
Product Code
DZL
Product Code Name
Screw, Fixation, Intraosseous
Public Device Record Key
4043e6ca-7ad4-4913-9cb1-058706cc2414
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 |