Clearance Summary
SOLID CORE GUTTA PERCHA CARRIER received FDA 510(k) clearance under submission number K905640, sponsored by The Hygenic 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 1991-03-05.
- Submission: K905640
- Applicant / Sponsor: The Hygenic Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1991-03-05
Classification & Regulation
This clearance is catalogued under FDA product code EKS and 21 CFR 872.4565, within the Dental review panel as a Class I device.