Clearance Summary
TCM ENDO III received FDA 510(k) clearance under submission number K013185, sponsored by NOUVAG AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2001-11-28.
- Submission: K013185
- Applicant / Sponsor: NOUVAG AG
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2001-11-28
Classification & Regulation
This clearance is catalogued under FDA product code EFA and 21 CFR 872.4200, within the Dental review panel as a Class I device.