Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in South KoreaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list MegaGen Implant with 32 510(k) clearances. The most recent is a 510(k) clearance dated Jun 18, 2026: MegaGen Zygoma Dental Implant System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 18, 2026 | MegaGen Zygoma Dental Implant SystemK251232 · DZE | 510(k) clearances |
| Jan 13, 2025 | MegaGen Dental Implant AbutmentK242030 · NHA | 510(k) clearances |
| Dec 27, 2024 | BLUEDIAMOND IMPLANTK241972 · DZE | 510(k) clearances |
| Sep 18, 2024 | TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentK234142 · NHA | 510(k) clearances |
| Mar 21, 2024 | N2K240754 · EIA | 510(k) clearances |
| Jan 22, 2024 | 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 ScrewK233450 · NHA | 510(k) clearances |
| Dec 7, 2023 | ARi ExCon Implant SystemK231967 · DZE | 510(k) clearances |
| Oct 20, 2023 | R2GATE Lite TMK223909 · LLZ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
