Clearance Summary
BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P received FDA 510(k) clearance under submission number K101064, sponsored by Bredent GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2010-09-14.
- Submission: K101064
- Applicant / Sponsor: Bredent GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3590
- Decision date: 2010-09-14
Classification & Regulation
This clearance is catalogued under FDA product code ELM and 21 CFR 872.3590, within the Dental review panel as a Class II device.