Clearance Summary
FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 2000 received FDA 510(k) clearance under submission number K052073, sponsored by Schutz-Dental GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2005-10-26.
- Submission: K052073
- Applicant / Sponsor: Schutz-Dental GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3760
- Decision date: 2005-10-26
Classification & Regulation
This clearance is catalogued under FDA product code EBI and 21 CFR 872.3760, within the Dental review panel as a Class II device.