Clearance Summary
DENTAL X-RAY BITE BLOCK received FDA 510(k) clearance under submission number K890355, sponsored by Bite-A-Block. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1989-06-12.
- Submission: K890355
- Applicant / Sponsor: Bite-A-Block
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.1905
- Decision date: 1989-06-12
Classification & Regulation
This clearance is catalogued under FDA product code EGZ and 21 CFR 872.1905, within the Dental review panel as a Class I device.