FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
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
K Number: K233450
·
Decision Jan 22, 2024
Classifications
1
FEI Numbers
390
Registration Numbers
390
Same Product Code
672
Applicant Total
16
Review Days
94
Basic Information
- 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
- K Number
- K233450
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MegaGen Implant Co., Ltd.
- Date Received
- October 20, 2023
- Decision Date
- January 22, 2024
- Product Code
- NHA
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | FDA class 2 | Dental |
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Other Clearances by MegaGen Implant Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K242030 | MegaGen Dental Implant Abutment | Jan 13, 2025 | Substantially Equivalent |
| K234142 | TiGEN Abutment, PMMA Abutment and Scan Healing Abutment | Sep 18, 2024 | Substantially Equivalent |
| K240754 | N2 | Mar 21, 2024 | Substantially Equivalent |
| K231967 | ARi ExCon Implant System | Dec 7, 2023 | Substantially Equivalent |
| K230618 | MegaGen Dental Implant Systems Portfolio - MR Conditional | Oct 11, 2023 | Substantially Equivalent |
| K223339 | Bone Chamber Implant | Jul 18, 2023 | Substantially Equivalent |
| K211556 | N2 | Apr 5, 2023 | Substantially Equivalent |
| K211812 | BLUEDIAMOND IMPLANT, Abutment Screw | Jan 6, 2023 | Substantially Equivalent |
| K220562 | TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment | Nov 10, 2022 | Substantially Equivalent |
| K210826 | Healing Abutment, Cover Screw | Feb 3, 2022 | Substantially Equivalent |