510(k) K213742
K213742 is an FDA 510(k) premarket notification submitted by Olsen Indústria E Comércio S.A. for the device "Infinity Pro, Logic, Quality, Sprint". The FDA issued a decision of Substantially Equivalent on October 19, 2022. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 19, 2022
- Date Received
- November 29, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Operative Dental
- Device Class
- Class I
- Regulation Number
- 872.6640
- Review Panel
- DE
- Submission Type