Clearance Summary
TIA Tip, Cariosity, Transillumination Accessory Tip received FDA 510(k) clearance under submission number K213482, sponsored by D4D Technologies, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2022-04-29.
- Submission: K213482
- Applicant / Sponsor: D4D Technologies, LLC
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1745
- Decision date: 2022-04-29
Classification & Regulation
This clearance is catalogued under FDA product code NTK and 21 CFR 872.1745, within the Dental review panel as a Class II device.