Duns Number:439240722
Device Description: DISPOSABLE Titanium device with tilting head to be cemented into the root canal, with rete DISPOSABLE Titanium device with tilting head to be cemented into the root canal, with retentive pink caps, metal housing for the caps, directional rings and protective disc.
Catalog Number
033PSF9R
Brand Name
ENDODONTIC POSTS
Version/Model Number
PIVOT FLEX mm.9
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
e9c56444-e0c7-43ba-bb38-595e5e5395f2
Public Version Date
August 03, 2021
Public Version Number
1
DI Record Publish Date
July 26, 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 | 1269 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1987 |