Clearance Summary
SIMPLER TOADSTOOL ABUTMENT, MODEL S19000-S19009 received FDA 510(k) clearance under submission number K093975, sponsored by Pan Global Implant. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2010-06-04.
- Submission: K093975
- Applicant / Sponsor: Pan Global Implant
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3630
- Decision date: 2010-06-04
Classification & Regulation
This clearance is catalogued under FDA product code NHA and 21 CFR 872.3630, within the Dental review panel as a Class II device.