Duns Number:343831731
Device Description: Apex-cable-Setfor Endopilot, consist of:1x measuring cable with plug;1x lip clip;1x cap fo Apex-cable-Setfor Endopilot, consist of:1x measuring cable with plug;1x lip clip;1x cap for lip contact;1x cable for file clamp;1x file clamp, dismountable;1x Bushing for lip-clip cable-socket
Catalog Number
109 2311
Brand Name
EndoPilot apex cable set
Version/Model Number
EDP2
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
K202906
Product Code
LQY
Product Code Name
Locator, Root Apex
Public Device Record Key
2384df8d-de39-4857-bba0-0a1df5d95d78
Public Version Date
June 08, 2021
Public Version Number
1
DI Record Publish Date
May 31, 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 | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 6 |