Duns Number:688322841
Device Description: Nonmetal instrument access the root cannel to fixate and support the prosthetics on the to Nonmetal instrument access the root cannel to fixate and support the prosthetics on the tooth after the root cannel treatment.
Catalog Number
-
Brand Name
NexPost Fiber #1 ø1.5
Version/Model Number
9395
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
ELR
Product Code Name
Post, Root Canal
Public Device Record Key
8e39c45c-a495-4b31-a818-8111032d3f30
Public Version Date
October 03, 2022
Public Version Number
1
DI Record Publish Date
September 24, 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 | 1335 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 284 |