Clearance Summary
PM2002 PROLINE received FDA 510(k) clearance under submission number K923534, sponsored by Planmeca USA, 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 1994-01-31.
- Submission: K923534
- Applicant / Sponsor: Planmeca USA, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6250
- Decision date: 1994-01-31
Classification & Regulation
This clearance is catalogued under FDA product code KLC and 21 CFR 872.6250, within the Dental review panel as a Class I device.