Duns Number:011050583
Device Description: Lower Left 1st Bicuspid .018 Roth Rx Direct Bond Composite Orthodontic Bracket
Catalog Number
710-723T
Brand Name
Comp Plus "T"™ LL 1st Bicuspid Roth .018
Version/Model Number
710-723T
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DYW
Product Code Name
Bracket, Plastic, Orthodontic
Public Device Record Key
321fa641-704c-41ff-847a-f863141fea9b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 67 |