Duns Number:009051723
Device Description: One foot of stainless steel threaded wire that can be cut to length for pins and posts. Th One foot of stainless steel threaded wire that can be cut to length for pins and posts. The smaller diameter are used for dentin pins giving better retention to amalgam fillings on vital teeth. A variety of diameters are used for endo posts to strengthen and build up endodontically treated teeth. The threaded nature of the wire provides for better retention.
Catalog Number
38018
Brand Name
Markley Threaded Wire .018
Version/Model Number
38018
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EBL
Product Code Name
Pin, Retentive And Splinting, And Accessory Instruments
Public Device Record Key
459ad414-609c-4810-8f32-5d21452ec44e
Public Version Date
October 23, 2019
Public Version Number
2
DI Record Publish Date
July 26, 2019
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |