Clearance Summary
TEMP. CROWN ACRYLIC RESIN received FDA 510(k) clearance under submission number K771530, sponsored by J. Palmero Sales Co., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1977-08-25.
- Submission: K771530
- Applicant / Sponsor: J. Palmero Sales Co., Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3770
- Decision date: 1977-08-25
Classification & Regulation
This clearance is catalogued under FDA product code EBG and 21 CFR 872.3770, within the Dental review panel as a Class II device.