Clearance Summary
PRECAPSULED DENTAL AMALGAM received FDA 510(k) clearance under submission number K822610, sponsored by Syntex Dental Products, 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 1982-09-14.
- Submission: K822610
- Applicant / Sponsor: Syntex Dental Products, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3110
- Decision date: 1982-09-14
Classification & Regulation
This clearance is catalogued under FDA product code DZS and 21 CFR 872.3110, within the Dental review panel as a Class I device.