The following data is part of a premarket notification filed by Olsen Indústria E Comércio S.a. with the FDA for Infinity Pro, Logic, Quality, Sprint.
| Device ID | K213742 |
| 510k Number | K213742 |
| Device Name: | Infinity Pro, Logic, Quality, Sprint |
| Classification | Unit, Operative Dental |
| Applicant | Olsen Indústria E Comércio S.A. Av. Ivo Luchi, 68 Palhoça, BR 88133-510 |
| Contact | Ana Cláudia Espíndola |
| 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 | 2021-11-29 |
| Decision Date | 2022-10-19 |