Clearance Summary
INSTA-GLAZE received FDA 510(k) clearance under submission number K854588, sponsored by George Taub Products & Fusion Co., 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 1986-02-04.
- Submission: K854588
- Applicant / Sponsor: George Taub Products & Fusion Co., Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6030
- Decision date: 1986-02-04
Classification & Regulation
This clearance is catalogued under FDA product code EJR and 21 CFR 872.6030, within the Dental review panel as a Class I device.