| Primary Device ID | D82851001560 |
| NIH Device Record Key | f2dbf280-20bf-4df4-87e6-cecefbab5eac |
| Commercial Distribution Discontinuation | 2023-02-10 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Bioliner Plus |
| Version Model Number | 5100156 |
| Company DUNS | 113352686 |
| Company Name | FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC |
| Device Count | 1 |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D82851001560 [Primary] |
| DYJ | Retainer, Screw Expansion, 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 | 2023-02-20 |
| Device Publish Date | 2023-02-10 |
| D82851001560 - Bioliner Plus | 2023-02-20 |
| D82851001560 - Bioliner Plus | 2023-02-20 |
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| D8281330171 - ULTRA BAND LOK CLEAR | 2018-07-06 |
| D8281330205 - LIGHT BOND PASTE TIPS | 2018-07-06 |
| D8281330206 - SKINNY NOSE LIGHT BOND PASTE TIPS | 2018-07-06 |
| D82813302070 - LIGHT BOND SYRINGE | 2018-07-06 |