Clearance Summary
ROEKO SEAL received FDA 510(k) clearance under submission number K983037, sponsored by Roeko Ulm, Roescheisen GmbH & 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 1998-10-20.
- Submission: K983037
- Applicant / Sponsor: Roeko Ulm, Roescheisen GmbH & Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3820
- Decision date: 1998-10-20
Classification & Regulation
This clearance is catalogued under FDA product code KIF and 21 CFR 872.3820, within the Dental review panel as a Class II device.