Duns Number:078474365
Device Description: Universal diamond-coated apical surgery tip for the retro-preparation of canals of anterio Universal diamond-coated apical surgery tip for the retro-preparation of canals of anterior
Catalog Number
-
Brand Name
EdgeSurgicalTip™ #1
Version/Model Number
AS3D1
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
-
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
ELC
Product Code Name
Scaler, Ultrasonic
Public Device Record Key
e7bdd804-ff29-43be-8ce7-ac7faae6b2ea
Public Version Date
February 21, 2019
Public Version Number
2
DI Record Publish Date
June 10, 2018
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 25 |
| U | Unclassified | 3 |