Clearance Summary
ULS 8-86 received FDA 510(k) clearance under submission number K863163, sponsored by American Instrument Manufacturer'S, 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 1986-09-22.
- Submission: K863163
- Applicant / Sponsor: American Instrument Manufacturer'S, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 1986-09-22
Classification & Regulation
This clearance is catalogued under FDA product code DYN and 21 CFR 872.6640, within the Dental review panel as a Class I device.