Clearance Summary
MYERSON R&KENSON R PORCELAIN ANT&POS.- received FDA 510(k) clearance under submission number K800829, sponsored by Myerson Tooth Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1980-05-08.
- Submission: K800829
- Applicant / Sponsor: Myerson Tooth Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3920
- Decision date: 1980-05-08
Classification & Regulation
This clearance is catalogued under FDA product code ELL and 21 CFR 872.3920, within the Dental review panel as a Class II device.