Clearance Summary
HANDPIECE MODELS: MS-350;RS-350;N-270 AIR-MOTOR received FDA 510(k) clearance under submission number K926154, 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 1994-03-04.
- Submission: K926154
- Applicant / Sponsor: Dabi-Atlante America Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 1994-03-04
Classification & Regulation
This clearance is catalogued under FDA product code EFB and 21 CFR 872.4200, within the Dental review panel as a Class I device.