Clearance Summary
DENTURE ADHESIVE SEALS received FDA 510(k) clearance under submission number K831493, sponsored by Johnson & Johnson Professionals, 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 1983-06-30.
- Submission: K831493
- Applicant / Sponsor: Johnson & Johnson Professionals, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3490
- Decision date: 1983-06-30
Classification & Regulation
This clearance is catalogued under FDA product code KOT and 21 CFR 872.3490, within the Dental review panel as a Class I device.