| Primary Device ID | 07290017528274 |
| NIH Device Record Key | e8c6e474-d495-41e3-aeb7-a81fca1ae834 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Infinix Flowable Composite |
| Version Model Number | INF-FL-FP-SD-A2 |
| Company DUNS | 532282466 |
| Company Name | NOBIO LTD |
| Device Count | 15 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| 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 |
|---|---|
| GS1 | 07290017528274 [Unit of Use] |
| GS1 | 17290017528271 [Primary] |
| EBF | Material, Tooth Shade, Resin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-23 |
| Device Publish Date | 2021-03-15 |
| 07290017528281 | Dental Composite - A3 shade Single dose |
| 07290017528274 | Dental Composite - A2 shade Single dose |
| 07290017528267 | Dental Composite - A1 shade Single dose |
| 17290017528257 | Dental Composite - A3 shade Multi dose |
| 17290017528240 | Dental Composite - A2 shade Multi dose 2g for re-fills kits |
| 07290017528205 | Dental Composite - A2 shade Multi dose 1g for starter kit |
| 17290017528233 | Dental Composite - A1 shade |