Clearance Summary
DentCare Aligners received FDA 510(k) clearance under submission number K222918, sponsored by Dentcare Dental Lab Pvt , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2022-11-25.
- Submission: K222918
- Applicant / Sponsor: Dentcare Dental Lab Pvt , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5470
- Decision date: 2022-11-25
Classification & Regulation
This clearance is catalogued under FDA product code NXC and 21 CFR 872.5470, within the Dental review panel as a Class II device.