# Megagen Implant Co., Ltd.

- Location (FDA's records): Daegu, KR
- FDA decisions: 32 (2008–2026): 32 510(k) clearances
- Product codes: DZE (17), NHA (7), LYC (2), LLZ (2), EIA (2), JEY (1), OAS (1)
- 510(k) review time since 2016: median 219 days, against 194 for FDA's reviews in the same codes and years (9 of 23 faster)
- Predicates its devices cite: 45 (15 its own); citations of its devices by later devices: 35 (15 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Megagen Co., Ltd.: 11 (https://510kreport.com/company/megagen)
- Institut Straumann AG: 2 (https://510kreport.com/company/institut-straumann)
- Osstem Implant Co., Ltd.: 2 (https://510kreport.com/company/osstem-implant)
- Noris Medical, Ltd.: 2 (https://510kreport.com/company/noris-medical)
- Southern Implants (Pty), Ltd.: 1 (https://510kreport.com/company/southern-implants)
- Blue Sky Bio, LLC: 1 (https://510kreport.com/company/blue-sky-bio)
- Dentium Co., Ltd.: 1 (https://510kreport.com/company/dentium)
- Biomatlante: 1 (https://510kreport.com/company/biomatlante)

## Firms that cite its devices most
- Integrated Dental Systems, LLC: 3 (https://510kreport.com/company/integrated-dental-systems)
- Oco Biomedical: 2 (https://510kreport.com/company/oco-biomedical)
- Dentis Co., Ltd.: 2 (https://510kreport.com/company/dentis)
- Truabutment, Inc.: 1 (https://510kreport.com/company/truabutment)
- Proimtech Saglik Urunleri Anonim Sirketi: 1 (https://510kreport.com/company/proimtech-saglik-urunleri-anonim-sirketi)
- Allonus Tech Co., Ltd.: 1 (https://510kreport.com/company/allonus-tech)
- Cowellmedi Co., Ltd.: 1 (https://510kreport.com/company/cowellmedi)
- Eclectic Co., Ltd.: 1 (https://510kreport.com/company/eclectic)

## Its most-cited devices
- K182448: AnyRidge Octa 1 Implant System (2019), cited by 7
- K123988: Anyonetm Internal Implant System (2013), cited by 5
- K122231: Xpeed Any Ridge Internal Implant System (2012), cited by 5
- K081302: Rescue External Implant System (2008), cited by 3
- K210826: Healing Abutment, Cover Screw (2022), cited by 3
- K220562: TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment (2022), cited by 3

## Recent decisions
- K251232: MegaGen Zygoma Dental Implant System (Jun 18, 2026)
- K242030: MegaGen Dental Implant Abutment (Jan 13, 2025)
- K241972: Bluediamond Implant (Dec 27, 2024)
- K234142: TiGEN Abutment, PMMA Abutment and Scan Healing Abutment (Sep 18, 2024)
- K240754: N2 (Mar 21, 2024)
- K233450: 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 (Jan 22, 2024)
- K231967: ARi ExCon Implant System (Dec 7, 2023)
- K223909: R2GATE Lite TM (Oct 20, 2023)

Source page: https://510kreport.com/company/megagen-implant