Clearance Summary
PULPDENT POLYAMIDE DENTIN LINER received FDA 510(k) clearance under submission number K911285, sponsored by Pulpdent 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 1991-10-09.
- Submission: K911285
- Applicant / Sponsor: Pulpdent Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1991-10-09
Classification & Regulation
This clearance is catalogued under FDA product code EME and 21 CFR 872.4565, within the Dental review panel as a Class I device.