Clearance Summary
SURGmatic S15 L Pro received FDA 510(k) clearance under submission number K213139, sponsored by Kavo Dental GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2021-12-21.
- Submission: K213139
- Applicant / Sponsor: Kavo Dental GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2021-12-21
Classification & Regulation
This clearance is catalogued under FDA product code EGS and 21 CFR 872.4200, within the Dental review panel as a Class I device.