Clearance Summary
PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT received FDA 510(k) clearance under submission number K082115, sponsored by S & C Polymer 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 2009-01-15.
- Submission: K082115
- Applicant / Sponsor: S & C Polymer GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3275
- Decision date: 2009-01-15
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.