Clearance Summary
DYRACT(TM) MATERIAL received FDA 510(k) clearance under submission number K945364, sponsored by Denstply Detrey-Dedent. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1994-12-29.
- Submission: K945364
- Applicant / Sponsor: Denstply Detrey-Dedent
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3690
- Decision date: 1994-12-29
Classification & Regulation
This clearance is catalogued under FDA product code EBF and 21 CFR 872.3690, within the Dental review panel as a Class II device.