Clearance Summary
ISOSIT TEETH received FDA 510(k) clearance under submission number K810970, sponsored by Bauer, Cheng & Associates, 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 1981-05-05.
- Submission: K810970
- Applicant / Sponsor: Bauer, Cheng & Associates, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3590
- Decision date: 1981-05-05
Classification & Regulation
This clearance is catalogued under FDA product code ELM and 21 CFR 872.3590, within the Dental review panel as a Class II device.