Duns Number:480610476
Device Description: Contra Angle 16:1 Endodontics
Catalog Number
-
Brand Name
Contra Angle 16:1 Endodontics
Version/Model Number
5061NOU
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
-
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
K022505
Product Code
EGS
Product Code Name
Handpiece, Contra- And Right-Angle Attachment, Dental
Public Device Record Key
ba8b9720-37bc-4248-86e5-24d4fda1fac3
Public Version Date
September 21, 2018
Public Version Number
1
DI Record Publish Date
August 21, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 72 |
2 | A medical device with a moderate to high risk that requires special controls. | 95 |