Clearance Summary
ANATOM SYSTEM received FDA 510(k) clearance under submission number K843233, sponsored by Lic-Orthion. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1984-10-25.
- Submission: K843233
- Applicant / Sponsor: Lic-Orthion
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6250
- Decision date: 1984-10-25
Classification & Regulation
This clearance is catalogued under FDA product code KLC and 21 CFR 872.6250, within the Dental review panel as a Class I device.