Duns Number:626406016
Device Description: Endodontic paper point
Catalog Number
865425
Brand Name
EndoEssentials™ Absorbent Paper Points 100 - #25 .04 Taper
Version/Model Number
865425
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EKN
Product Code Name
POINT, PAPER, ENDODONTIC
Public Device Record Key
bb0f5469-e396-4696-98d4-214b4fbdee02
Public Version Date
March 25, 2020
Public Version Number
1
DI Record Publish Date
March 17, 2020
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 | 1461 |
2 | A medical device with a moderate to high risk that requires special controls. | 234 |
U | Unclassified | 6 |