Duns Number:113170088
Device Description: The C&C system is intended for use by a dental professional for extrusion of an impacted t The C&C system is intended for use by a dental professional for extrusion of an impacted tooth. Kit contains 3 Disposable Oval Attachments with Chain and 2 Disposable Pad Attachments with Chain, Flowtain adhesive and Assure Universal Bonding Resin.
Catalog Number
DCCK
Brand Name
C&C
Version/Model Number
DCCK
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 07, 2017
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
ff382ffb-e48c-4b92-9e5b-9471563c90ab
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 |