Clearance Summary
ONE WEEK BACKSTOP DENTAL ANTI-RETRACTION CHECK VALVE received FDA 510(k) clearance under submission number K982009, sponsored by Scitech Solutions, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1998-06-25.
- Submission: K982009
- Applicant / Sponsor: Scitech Solutions, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 1998-06-25
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.