Clearance Summary
UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio received FDA 510(k) clearance under submission number K232498, sponsored by Ultradent Product, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2023-08-18.
- Submission: K232498
- Applicant / Sponsor: Ultradent Product, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3765
- Decision date: 2023-08-18
Classification & Regulation
This clearance is catalogued under FDA product code EBC and 21 CFR 872.3765, within the Dental review panel as a Class II device.