Clearance Summary
DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANT received FDA 510(k) clearance under submission number K091735, 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 2009-09-25.
- Submission: K091735
- Applicant / Sponsor: S & C Polymer GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3275
- Decision date: 2009-09-25
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.