Clearance Summary
DIMENSION PENTA/DIMENSION GARANT L/POLYVINYL SILOXANE ADHESIVE received FDA 510(k) clearance under submission number K960547, 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 1996-03-15.
- Submission: K960547
- Applicant / Sponsor: Espe GmbH & Co. Kg.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3660
- Decision date: 1996-03-15
Classification & Regulation
This clearance is catalogued under FDA product code ELW and 21 CFR 872.3660, within the Dental review panel as a Class II device.