Clearance Summary
REPOSITIONABLE BITEWING X-RAY FILM HOLDER KIT received FDA 510(k) clearance under submission number K891186, sponsored by Benn Research , 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 1989-04-12.
- Submission: K891186
- Applicant / Sponsor: Benn Research , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.1820
- Decision date: 1989-04-12
Classification & Regulation
This clearance is catalogued under FDA product code EHA and 21 CFR 872.1820, within the Dental review panel as a Class I device.