Clearance Summary
PARAPOST XT SYSTEM received FDA 510(k) clearance under submission number K934192, sponsored by Coltene/Whaledent, 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 1994-06-06.
- Submission: K934192
- Applicant / Sponsor: Coltene/Whaledent, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3810
- Decision date: 1994-06-06
Classification & Regulation
This clearance is catalogued under FDA product code ELR and 21 CFR 872.3810, within the Dental review panel as a Class I device.