Clearance Summary
HANDPIECE MODELS MS-350, RS-350; AIR MOTOR N-270 received FDA 510(k) clearance under submission number K922437, 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 1992-12-21.
- Submission: K922437
- Applicant / Sponsor: Dabi-Atlante America Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 1992-12-21
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.