Clearance Summary
TEFGEN - LS received FDA 510(k) clearance under submission number K965205, sponsored by American Custom Medical, 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 1997-04-30.
- Submission: K965205
- Applicant / Sponsor: American Custom Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3930
- Decision date: 1997-04-30
Classification & Regulation
This clearance is catalogued under FDA product code NPK and 21 CFR 872.3930, within the Dental review panel as a Class II device.