Clearance Summary
TEMPOFIT, MODEL 02693 received FDA 510(k) clearance under submission number K994012, sponsored by Detax GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2000-02-16.
- Submission: K994012
- Applicant / Sponsor: Detax GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3770
- Decision date: 2000-02-16
Classification & Regulation
This clearance is catalogued under FDA product code EBG and 21 CFR 872.3770, within the Dental review panel as a Class II device.