Duns Number:439240722
Device Description: DISPOSABLE titanium device with low profile head to be cemented into the root canal
Catalog Number
333PEK7
Brand Name
ENDODONTIC POSTS
Version/Model Number
PIVOT tit. EQUATOR mm.7 set
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 20, 2021
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
-
Product Code
ELR
Product Code Name
Post, Root Canal
Public Device Record Key
13cec55c-462d-4d7c-85d3-3c672b5fbc3b
Public Version Date
January 21, 2021
Public Version Number
2
DI Record Publish Date
January 04, 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 |