Clearance Summary
NIPRO DENTAL NEEDLE received FDA 510(k) clearance under submission number K894373, sponsored by Pharma-Plast USA, 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 1989-10-13.
- Submission: K894373
- Applicant / Sponsor: Pharma-Plast USA, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4730
- Decision date: 1989-10-13
Classification & Regulation
This clearance is catalogued under FDA product code DZM and 21 CFR 872.4730, within the Dental review panel as a Class I device.