Clearance Summary
CAT. 8 DENTAL DEVICES received FDA 510(k) clearance under submission number K840312, sponsored by Imm Enterprises , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1984-04-05.
- Submission: K840312
- Applicant / Sponsor: Imm Enterprises , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1984-04-05
Classification & Regulation
This clearance is catalogued under FDA product code EMG and 21 CFR 872.4565, within the Dental review panel as a Class I device.