Clearance Summary
DD Bio Z, DD Bio ZX(square), DD BioZX(square) color received FDA 510(k) clearance under submission number K142987, sponsored by Dental Direkt of Amerika UG (Haftungsbeschraenkt). The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2015-02-11.
- Submission: K142987
- Applicant / Sponsor: Dental Direkt of Amerika UG (Haftungsbeschraenkt)
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6660
- Decision date: 2015-02-11
Classification & Regulation
This clearance is catalogued under FDA product code EIH and 21 CFR 872.6660, within the Dental review panel as a Class II device.