Duns Number:831465641
Device Description: PRISM™ ROTH .022 FULL SET. UPPER/LOWER 5X5 HOOK ON 3, 4, & 5. WITH CASE AND TUBES. (5X KIT PRISM™ ROTH .022 FULL SET. UPPER/LOWER 5X5 HOOK ON 3, 4, & 5. WITH CASE AND TUBES. (5X KIT)Prism™ composite brackets. Not only are Prism™ composite brackets nearly invisible, but also the special composite formulation from which the device is manufactured produces a bracket that displays a high tensile strength. The result is a strong polyurethane bracket with superior sliding mechanics that are equal to or greater than stainless steel brackets.
Catalog Number
-
Brand Name
PRISM™ ROTH COMPOSITE BRACKETS (KIT)
Version/Model Number
45K-345-22-05S
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
0289bc3f-c8ad-4f3a-bddd-9164bf06f75f
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 |