Duns Number:831465641
Device Description: KIT ZENITH™ ROTH COMP 5-5 3,4,5 022 W/HKS X5Zenith™ Series Composite [CM] aesthetic bracke KIT ZENITH™ ROTH COMP 5-5 3,4,5 022 W/HKS X5Zenith™ Series Composite [CM] aesthetic brackets are precision designed and manufactured so that no special treatment mechanics or bonding procedures are necessary. All of the same clinical techniques routinely used with metal brackets are applicable with Zenith™.Zenith™ brackets are designed with all the features needed to achieve contemporary treatment objectives including rounded contours for comfort and reduced friction, sweeping tie wing undercuts, notched bases for mechanical bonds, plus many more.
Catalog Number
-
Brand Name
ZENITH™ ROTH COMPOSITE BRACKETS (KIT)
Version/Model Number
KTRCM2355V
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
K973776
Product Code
DYW
Product Code Name
Bracket, Plastic, Orthodontic
Public Device Record Key
439ed1fb-e6b1-42e5-bfdc-a2b060f59a4e
Public Version Date
July 06, 2018
Public Version Number
3
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 288 |