Clearance Summary
ORAPIK PERIODONTAL SCALER received FDA 510(k) clearance under submission number K844238, sponsored by Dental Concepts, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1984-12-03.
- Submission: K844238
- Applicant / Sponsor: Dental Concepts, LLC
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6650
- Decision date: 1984-12-03
Classification & Regulation
This clearance is catalogued under FDA product code JET and 21 CFR 872.6650, within the Dental review panel as a Class I device.