Clearance Summary
MINIFLEX AND PERSONAL UNIT received FDA 510(k) clearance under submission number K912997, sponsored by Dabi-Atlante America Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1991-10-30.
- Submission: K912997
- Applicant / Sponsor: Dabi-Atlante America Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4630
- Decision date: 1991-10-30
Classification & Regulation
This clearance is catalogued under FDA product code EAZ and 21 CFR 872.4630, within the Dental review panel as a Class I device.