K233450
- 510(k) number
- K233450
- Device name
- MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw
- Applicant
- Megagen Implant Co., Ltd. KR
- Product code
- NHA — Abutment, Implant, Dental, Endosseous
- Decision date
- 2024-01-22
- Date received
- 2023-10-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K233450.pdf
Official FDA record: K233450
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.