Clearance Summary
PacTemp Automix NE received FDA 510(k) clearance under submission number K261937, sponsored by The Belport Company Inc., DBA Gingi-Pak. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2026-08-07.
- Submission: K261937
- Applicant / Sponsor: The Belport Company Inc., DBA Gingi-Pak
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3275
- Decision date: 2026-08-07
Classification & Regulation
This clearance is catalogued under FDA product code EMA and 21 CFR 872.3275, within the Dental review panel as a Class II device.