Duns Number:005432299
Device Description: Upper 5-5 Cuspid/Bicuspid W/Hook Clear Vu̫ Mini Ceramic All Remaining Brackets Lower 5-5 Upper 5-5 Cuspid/Bicuspid W/Hook Clear Vu̫ Mini Ceramic All Remaining Brackets Lower 5-5 Nu-Edge̫ Metal 0.46 mm (.018") Bondable
Catalog Number
-
Brand Name
ClearVu Mini Ceramic Brackets
Version/Model Number
297-031CV
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K950992
Product Code
NJM
Product Code Name
Bracket, ceramic, orthodontic
Public Device Record Key
f24bb64e-27cb-4326-9045-3b180d0ff5bf
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 19, 2019
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 | 2591 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 715 |