The following data is part of a premarket notification filed by Nobio Ltd. with the FDA for Infinix Universal Composite.
| Device ID | K182921 |
| 510k Number | K182921 |
| Device Name: | Infinix Universal Composite |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Nobio Ltd. 8 Hamatechet St. Kadima, IL 6092000 |
| Contact | Inbal Beinglass Peled |
| Correspondent | Shoshana Friedman ProMedoss, Inc. 3521 Hatwynn Rd. Charlotte, NC 28269 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-19 |
| Decision Date | 2019-09-13 |
| Summary: | summary |