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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 (

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K233450
510(k) Type
Traditional
Applicant
MegaGen Implant Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
1/22/2024
Days to Decision
94 days
Submission Type
Summary

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 (

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K233450
510(k) Type
Traditional
Applicant
MegaGen Implant Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
1/22/2024
Days to Decision
94 days
Submission Type
Summary