Clearance Summary
SMITH S-100 TIME & TEMPERATURE CONTROL received FDA 510(k) clearance under submission number K955825, sponsored by Smith Companies Dental Products. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1996-04-05.
- Submission: K955825
- Applicant / Sponsor: Smith Companies Dental Products
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1900
- Decision date: 1996-04-05
Classification & Regulation
This clearance is catalogued under FDA product code EGY and 21 CFR 892.1900, within the Radiology review panel as a Class II device.