Clearance Summary
VIOLA II DENTAL CAMERA SYSTEM received FDA 510(k) clearance under submission number K973035, sponsored by Innovative Medical Systems, 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 1997-09-24.
- Submission: K973035
- Applicant / Sponsor: Innovative Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 1997-09-24
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.