Clearance Summary
PROTEMP(R) GARANT received FDA 510(k) clearance under submission number K950203, sponsored by Espe GmbH & Co. Kg.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1995-02-02.
- Submission: K950203
- Applicant / Sponsor: Espe GmbH & Co. Kg.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3770
- Decision date: 1995-02-02
Classification & Regulation
This clearance is catalogued under FDA product code EBG and 21 CFR 872.3770, within the Dental review panel as a Class II device.