Clearance Summary
ORAFIX SPECIAL DENTURE ADHESIVE received FDA 510(k) clearance under submission number K943486, sponsored by Smithkline Beecham 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 1994-11-03.
- Submission: K943486
- Applicant / Sponsor: Smithkline Beecham Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3490
- Decision date: 1994-11-03
Classification & Regulation
This clearance is catalogued under FDA product code KOO and 21 CFR 872.3490, within the Dental review panel as a Class I device.