Clearance Summary
SPIRIT II AND SPIRIT TREATMENT CENTER received FDA 510(k) clearance under submission number K946187, sponsored by Pelton & Crane Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1995-03-01.
- Submission: K946187
- Applicant / Sponsor: Pelton & Crane Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 1995-03-01
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.