The following data is part of a premarket notification filed by Olsen Insdustria De Equipamentos Odontomedicos with the FDA for Infinity / Infinity Cross Flex Dental Systems.
| Device ID | K180935 |
| 510k Number | K180935 |
| Device Name: | Infinity / Infinity Cross Flex Dental Systems |
| Classification | Unit, Operative Dental |
| Applicant | Olsen Insdustria De Equipamentos Odontomedicos Av. Ivo Luchi, 68 - Jardim Eldorado Palhoça -, BR 88133-510 |
| Contact | Ana Claudia Espindola |
| Correspondent | Lilian Llull TechLink International 16445 Collins Ave # 522 Sunny Isles, FL 33160 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-10 |
| Decision Date | 2020-02-05 |