Clearance Summary
DentureID Microchip received FDA 510(k) clearance under submission number K170423, sponsored by Cmp Industries, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2017-10-25.
- Submission: K170423
- Applicant / Sponsor: Cmp Industries, LLC
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6300
- Decision date: 2017-10-25
Classification & Regulation
This clearance is catalogued under FDA product code PYQ and 21 CFR 880.6300, within the General Hospital review panel as a Class II device.