| Primary Device ID | D798SK100 |
| NIH Device Record Key | 3fdaa661-5164-4977-8aa9-1a5b62f11107 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Kobayashi Tie Hooks |
| Version Model Number | SK10 |
| Company DUNS | 113170088 |
| Company Name | RELIANCE ORTHODONTIC PRODUCTS INC |
| Device Count | 100 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D798SK100 [Unit of Use] |
| HIBCC | D798SK101 [Primary] |
| DZC | Wire, Orthodontic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-30 |
| Device Publish Date | 2022-05-20 |
| D798UK141 | Kobayashi Tie Hooks are Intended for the use of ligating archwires and hooks to orthodontic brac |
| D798UK121 | Kobayashi Tie hooks are intended for the use in ligating archwires and hooks to orthodontic brac |
| D798SK121 | Kobayashi Tie Hooks are intended for use to secure rubber bands to a bracket and elastics. This |
| D798K141 | Kobayashi Tie Hooks are Intended for the use of ligating archwires and hooks to orthodontic brac |
| D798K121 | Kobayashi Tie hooks are intended for the use in ligating archwires and hooks to orthodontic brac |
| D798K101 | Kobayashi Tie Hooks are intended for the use in ligating archwires and hooks to orthodontic brac |
| D798SK100 | Kobayashi Tie Hooks are intended for use to secure rubber bands to a bracket and elastics. This |