Clearance Summary
P50 Series Dental Operative Unit and Accessories received FDA 510(k) clearance under submission number K171872, sponsored by Pelton & Crane. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2018-04-26.
- Submission: K171872
- Applicant / Sponsor: Pelton & Crane
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 2018-04-26
Classification & Regulation
This clearance is catalogued under FDA product code EIA and 21 CFR 872.6640, within the Dental review panel as a Class I device.