Clearance Summary
CARERITE BIOPACK GINGIVAL RETRACTION CORD received FDA 510(k) clearance under submission number K871736, sponsored by Cost Rite Health 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 1987-05-27.
- Submission: K871736
- Applicant / Sponsor: Cost Rite Health Products, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6390
- Decision date: 1987-05-27
Classification & Regulation
This clearance is catalogued under FDA product code JES and 21 CFR 872.6390, within the Dental review panel as a Class I device.