Duns Number:113170088
Device Description: Kobayashi Tie hooks are intended for the use in ligating archwires and hooks to orthodonti Kobayashi Tie hooks are intended for the use in ligating archwires and hooks to orthodontic brackets and elastics. Size 0.012
Catalog Number
UK12
Brand Name
Kobayashi Tie Hooks
Version/Model Number
UK12
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
DZC
Product Code Name
Wire, Orthodontic
Public Device Record Key
fb7a8c20-39b7-4655-b77d-add4a2b4dd51
Public Version Date
June 22, 2021
Public Version Number
3
DI Record Publish Date
September 12, 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 | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 279 |