MegaGen Dental Implant Abutment - Scan Healing Abutment +17 more— 510(k) K233450

Clearance details

Device name as filed

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.

Product code

Code NHA

Device class

Class 2

Regulation

21 CFR 872.3630

Advisory panel

Dental

Date received

2023-10-20

Decision date

2024-01-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Deagu, KR

• K253999 — Universal Base ASC Engaging +6 more2026-08-06
• K261147 — Neodent Implant System - NeoConvert Fit2026-07-01
• K261122 — MIST IC2026-06-27
• K260061 — BioHorizons CEREC Compatible Ti-Bases2026-06-26
• K253922 — Neodent Scannable Healing Abutment2026-06-15

• K251232 — MegaGen Zygoma Dental Implant System2026-06-18
• K242030 — MegaGen Dental Implant Abutment2025-01-13
• K241972 — BLUEDIAMOND IMPLANT2024-12-27
• K234142 — TiGEN Abutment, PMMA Abutment and Scan Healing Abutment2024-09-18
• K240754 — N22024-03-21

Injury

1,270

Malfunction

2,860

Total

4,130

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →