K182921 is an FDA 510(k) clearance for the Infinix Universal Composite. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Nobio , Ltd. (Kadima, IL). The FDA issued a Cleared decision on September 13, 2019, 329 days after receiving the submission on October 19, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K182921 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 2018 |
| Decision Date | September 13, 2019 |
| Days to Decision | 329 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBF - Material, Tooth Shade, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3690 |