Clearance Summary
EVO 700 series high speed handpiece received FDA 510(k) clearance under submission number K232243, sponsored by Ttbio Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2023-08-23.
- Submission: K232243
- Applicant / Sponsor: Ttbio Corp.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2023-08-23
Classification & Regulation
This clearance is catalogued under FDA product code EFB and 21 CFR 872.4200, within the Dental review panel as a Class I device.