Duns Number:315494443
Device Description: The ROEKO GuttaFlow®2 Introkit contains 1 x Capsules GuttaFlow®2 (20 pcs), 1 x Canal Tips The ROEKO GuttaFlow®2 Introkit contains 1 x Capsules GuttaFlow®2 (20 pcs), 1 x Canal Tips + Stops (20 pcs), 1 x Adapters for RotoMix™ (3 pcs), 1 x Dispenser, 1 x ROEKO Guttapercha points Top Color ISO 15-40 (100 pcs) and 1 x ROEKO Guttapercha points Greater Taper 0.04 20-45 (60 pcs).
Catalog Number
60013702
Brand Name
ROEKO GuttaFlow®2
Version/Model Number
INTROKIT
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
Yes
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
K032662
Product Code
EKM
Product Code Name
Gutta-Percha
Public Device Record Key
d7ac9cae-635a-40da-bf86-d387e50603b7
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 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 | 163 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 24 |
| U | Unclassified | 11 |