Clearance Summary
DENTAL IMPRESSION SYINGE received FDA 510(k) clearance under submission number K890357, sponsored by Innotek Dental Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1989-02-13.
- Submission: K890357
- Applicant / Sponsor: Innotek Dental Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1989-02-13
Classification & Regulation
This clearance is catalogued under FDA product code EKJ and 21 CFR 872.4565, within the Dental review panel as a Class I device.