Clearance Summary
BUR, DENTAL GUTTA PERCHA-FILE-PULP CANAL received FDA 510(k) clearance under submission number K842720, sponsored by Penn-Med Technology, 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 1985-05-21.
- Submission: K842720
- Applicant / Sponsor: Penn-Med Technology, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3240
- Decision date: 1985-05-21
Classification & Regulation
This clearance is catalogued under FDA product code EJL and 21 CFR 872.3240, within the Dental review panel as a Class I device.