Clearance Summary
ORALUBE received FDA 510(k) clearance under submission number K090457, sponsored by Pulpdent Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2009-05-21.
- Submission: K090457
- Applicant / Sponsor: Pulpdent Corporation
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6375
- Decision date: 2009-05-21
Classification & Regulation
This clearance is catalogued under FDA product code ONK and 21 CFR 880.6375, within the General Hospital review panel as a Class I device.