Clearance Summary
COMPOLUTE APLICAP received FDA 510(k) clearance under submission number K974458, sponsored by Espe Dental-Medizin 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 1998-02-02.
- Submission: K974458
- Applicant / Sponsor: Espe Dental-Medizin GmbH & Co.Kg.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3275
- Decision date: 1998-02-02
Classification & Regulation
This clearance is catalogued under FDA product code EMA and 21 CFR 872.3275, within the Dental review panel as a Class II device.