Duns Number:113170088
Device Description: This kit is used for extrusion of teeth. This is a chemical cure self mix kit containing 3 This kit is used for extrusion of teeth. This is a chemical cure self mix kit containing 3 Oval Attachments with Chain and 2 Pad Attachments with Chain, Excel Regular Self Mix syringe and Assure Bonding Resin.
Catalog Number
CCCCK
Brand Name
C&C
Version/Model Number
CCCCK
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 01, 2016
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
-
Product Code
DYH
Product Code Name
Adhesive, Bracket And Tooth Conditioner, Resin
Public Device Record Key
a6bd47d3-1e6f-49ba-8597-0b56ae674d37
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 25, 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 | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 279 |