Duns Number:113170088
Device Description: This product is intended for use by a dental professional for extrusion of an impacted too This product is intended for use by a dental professional for extrusion of an impacted tooth. Kit contains 3 Oval Attachments with Chain and 2 Pad Attachments with Chain, Flowtain adheisve and Assure Universal Bonding Resin.
Catalog Number
CCK
Brand Name
C&C
Version/Model Number
CCK
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 21, 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
32c60ddc-799b-4528-9209-e8ded8d3f705
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 |