Clearance Summary
IMPLANT, DENTAL, PYROLITE CARBON ENDO. received FDA 510(k) clearance under submission number K770440, sponsored by General Atomic Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1977-03-15.
- Submission: K770440
- Applicant / Sponsor: General Atomic Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 1977-03-15
Classification & Regulation
This clearance is catalogued under FDA product code DZE and 21 CFR 872.3640, within the Dental review panel as a Class II device.