Clearance Summary
MAGNETIC RETENTION UNIT received FDA 510(k) clearance under submission number K811237, sponsored by Universiti Malaya. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1981-06-16.
- Submission: K811237
- Applicant / Sponsor: Universiti Malaya
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6710
- Decision date: 1981-06-16
Classification & Regulation
This clearance is catalogued under FDA product code ECG and 21 CFR 872.6710, within the Dental review panel as a Class I device.