Duns Number:381582196
Device Description: Micro-blade tip, length 9mm,taper 5%The CAP2 tip has active lateral part andextremity and Micro-blade tip, length 9mm,taper 5%The CAP2 tip has active lateral part andextremity and is used by sweeping methodto remove dentine bridges.• Location of the MB2 (2nd mesiobuccal canal)and search for hidden canals.• Preparation of the pulp chamber.• Removal of the dentine layer which may hidethe access to the MB2 canal.
Catalog Number
F88182
Brand Name
ACTEON
Version/Model Number
TIP CAP2
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
5c7fd3f2-ef13-41e6-b12b-cd57e9700b91
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 416 |