Clearance Summary
DENTAL INSTRUMENTS SCALER received FDA 510(k) clearance under submission number K931330, sponsored by Minnesota Prophy Power, 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 1994-01-26.
- Submission: K931330
- Applicant / Sponsor: Minnesota Prophy Power, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1994-01-26
Classification & Regulation
This clearance is catalogued under FDA product code EMN and 21 CFR 872.4565, within the Dental review panel as a Class I device.