Clearance Summary
PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER) received FDA 510(k) clearance under submission number K101869, sponsored by Silmet , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2010-09-29.
- Submission: K101869
- Applicant / Sponsor: Silmet , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3275
- Decision date: 2010-09-29
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.