Clearance Summary
ZYGOMA 17 ABUTMENT MULTI-UNIT RP 2MM, MODEL 29314; ZYGOMA 17 ABUTMENT MULTI-UNIT RP 3MM, MODEL 29315 received FDA 510(k) clearance under submission number K052885, sponsored by Nobel Biocare USA, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2005-12-23.
- Submission: K052885
- Applicant / Sponsor: Nobel Biocare USA, LLC
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3630
- Decision date: 2005-12-23
Classification & Regulation
This clearance is catalogued under FDA product code NHA and 21 CFR 872.3630, within the Dental review panel as a Class II device.