Duns Number:316133664
Device Description: Mixing tips to attach to a cartridge. The cartridge is filled with 2-component impression Mixing tips to attach to a cartridge. The cartridge is filled with 2-component impression silicone, dental cement or similar.The mixing tip has a spiral inside with which the 2 components can be mixed and comes out mixed on the front. Used in dentistry.
Catalog Number
03570
Brand Name
Mixing Tips Core Colibri N11 green 25
Version/Model Number
03570
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
-
Product Code
EID
Product Code Name
Syringe, Restorative And Impression Material
Public Device Record Key
78cd29bb-abe9-4117-9816-dfff8daa1d46
Public Version Date
July 01, 2020
Public Version Number
1
DI Record Publish Date
June 23, 2020
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 | 32 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 74 |