Clearance Summary
STECO-TITANMAGNETICS received FDA 510(k) clearance under submission number K990979, sponsored by Steco-System-Technik GmbH & Cokg. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1999-09-03.
- Submission: K990979
- Applicant / Sponsor: Steco-System-Technik GmbH & Cokg
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3165
- Decision date: 1999-09-03
Classification & Regulation
This clearance is catalogued under FDA product code EGG and 21 CFR 872.3165, within the Dental review panel as a Class I device.