Clearance Summary
DynaMatrix/Dynamatrix Plus received FDA 510(k) clearance under submission number K161762, sponsored by Cook Biotech Incorporated. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2017-01-13.
- Submission: K161762
- Applicant / Sponsor: Cook Biotech Incorporated
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3930
- Decision date: 2017-01-13
Classification & Regulation
This clearance is catalogued under FDA product code NPL and 21 CFR 872.3930, within the Dental review panel as a Class II device.