Duns Number:008256356
Device Description: Clarity(TM) ADVANCED Ceramic/Victory Series(TM) Low Profile Bracket MBT(TM) U/L 5x5 3Hk .0 Clarity(TM) ADVANCED Ceramic/Victory Series(TM) Low Profile Bracket MBT(TM) U/L 5x5 3Hk .022 Kt
Catalog Number
006-161
Brand Name
Clarity™ ADVANCED Victory Series™ Low Profile
Version/Model Number
006-161
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 21, 2017
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NJM
Product Code Name
Bracket, ceramic, orthodontic
Public Device Record Key
1b932707-85af-4839-a7e9-120dc310a9b7
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 05, 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 | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 610 |