Clearance Summary
ULTRAFIL-LT (GUTTA PERCHA) received FDA 510(k) clearance under submission number K850863, 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 1985-04-16.
- Submission: K850863
- Applicant / Sponsor: The Hygenic Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3850
- Decision date: 1985-04-16
Classification & Regulation
This clearance is catalogued under FDA product code EKM and 21 CFR 872.3850, within the Dental review panel as a Class I device.