Clearance Summary
GELATO PROPHYLAXIS PASTE received FDA 510(k) clearance under submission number K042048, sponsored by Deepak Products, 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 2004-10-26.
- Submission: K042048
- Applicant / Sponsor: Deepak Products, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6030
- Decision date: 2004-10-26
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.