Clearance Summary
Spirit received FDA 510(k) clearance under submission number K143696, 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 2015-09-18.
- Submission: K143696
- Applicant / Sponsor: Pelton & Crane
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 2015-09-18
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.