Clearance Summary
MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM received FDA 510(k) clearance under submission number K961704, sponsored by Dentatus USA , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1996-07-26.
- Submission: K961704
- Applicant / Sponsor: Dentatus USA , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3890
- Decision date: 1996-07-26
Classification & Regulation
This clearance is catalogued under FDA product code ELS and 21 CFR 872.3890, within the Dental review panel as a Class II device.