Clearance Summary
PENTAMIX 2 received FDA 510(k) clearance under submission number K991913, sponsored by Espe Dental AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1999-07-26.
- Submission: K991913
- Applicant / Sponsor: Espe Dental AG
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3100
- Decision date: 1999-07-26
Classification & Regulation
This clearance is catalogued under FDA product code EFD and 21 CFR 872.3100, within the Dental review panel as a Class I device.