Clearance Summary
SPECULITE/ORALLITE received FDA 510(k) clearance under submission number K003995, sponsored by Trylon 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 2001-03-16.
- Submission: K003995
- Applicant / Sponsor: Trylon Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4630
- Decision date: 2001-03-16
Classification & Regulation
This clearance is catalogued under FDA product code EAZ and 21 CFR 872.4630, within the Dental review panel as a Class I device.