Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Megagen Implant Co., Ltd. · Predicate Candidate Screening
32 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
186 daysmedian FDA review time
422 days90th percentile
32clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251232 | MegaGen Zygoma Dental Implant System | Megagen Implant Co., Ltd. | 2026-06-18 | 422 | 0 |
| K242030 | MegaGen Dental Implant Abutment | Megagen Implant Co., Ltd. | 2025-01-13 | 186 | 0 |
| K241972 | BLUEDIAMOND IMPLANT | Megagen Implant Co., Ltd. | 2024-12-27 | 175 | 0 |
| K234142 | TiGEN Abutment, PMMA Abutment and Scan Healing Abutment | Megagen Implant Co., Ltd. | 2024-09-18 | 264 | 0 |
| K240754 | N2 | Megagen Implant Co., Ltd. | 2024-03-21 | 1 | 0 |
| K233450 | MegaGen Dental Implant Abutment - Scan Healing Abutment; Tem | Megagen Implant Co., Ltd. | 2024-01-22 | 94 | 0 |
| K231967 | ARi ExCon Implant System | Megagen Implant Co., Ltd. | 2023-12-07 | 157 | 0 |
| K223909 | R2GATE Lite TM | Megagen Implant Co., Ltd. | 2023-10-20 | 295 | 0 |
| K230618 | MegaGen Dental Implant Systems Portfolio - MR Conditional | Megagen Implant Co., Ltd. | 2023-10-11 | 219 | 0 |
| K223339 | Bone Chamber Implant | Megagen Implant Co., Ltd. | 2023-07-18 | 259 | 0 |
| K211556 | N2 | Megagen Implant Co., Ltd. | 2023-04-05 | 686 | 0 |
| K211812 | BLUEDIAMOND IMPLANT, Abutment Screw | Megagen Implant Co., Ltd. | 2023-01-06 | 574 | 0 |
| K222219 | R2 Studio Q/RCT820 | Megagen Implant Co., Ltd. | 2022-12-06 | 134 | 0 |
| K220562 | TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment | Megagen Implant Co., Ltd. | 2022-11-10 | 255 | 0 |
| K210826 | Healing Abutment, Cover Screw | Megagen Implant Co., Ltd. | 2022-02-03 | 321 | 0 |
| K203808 | Multi-unit Abutment, Multi-unit Angled Abutment | Megagen Implant Co., Ltd. | 2021-10-20 | 296 | 0 |
| K203554 | AnyOne External Implant System | Megagen Implant Co., Ltd. | 2021-08-28 | 267 | 0 |
| K210161 | AnyOne Onestage Implant System | Megagen Implant Co., Ltd. | 2021-06-22 | 152 | 0 |
| K192614 | Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abu | Megagen Implant Co., Ltd. | 2020-02-13 | 143 | 0 |
| K192347 | ST Internal Implant System | Megagen Implant Co., Ltd. | 2019-11-14 | 77 | 0 |
| K182448 | AnyRidge Octa 1 Implant System | Megagen Implant Co., Ltd. | 2019-10-09 | 397 | 0 |
| K191127 | Advanced Intermezzo Implant System | Megagen Implant Co., Ltd. | 2019-10-08 | 162 | 0 |
| K190096 | R2GATE | Megagen Implant Co., Ltd. | 2019-06-26 | 155 | 0 |
| K150537 | MiNi Internal Implant System | Megagen Implant Co., Ltd. | 2015-07-21 | 140 | 0 |
| K140091 | XPEED ANYRIDGE INTERNAL IMPLANT SYSYEM | Megagen Implant Co., Ltd. | 2014-12-12 | 332 | 0 |
| K131289 | I-GEN | Megagen Implant Co., Ltd. | 2013-09-25 | 142 | 0 |
| K123988 | ANYONETM INTERNAL IMPLANT SYSTEM | Megagen Implant Co., Ltd. | 2013-08-15 | 232 | 0 |
| K123870 | XPEED ANYRIDGE INTERNAL IMPLANT SYSTEM | Megagen Implant Co., Ltd. | 2013-03-27 | 100 | 0 |
| K122231 | XPEED ANY RIDGE INTERNAL IMPLANT SYSTEM | Megagen Implant Co., Ltd. | 2012-10-04 | 70 | 0 |
| K122240 | BONE PLUS BCP EAGLE EYE | Megagen Implant Co., Ltd. | 2012-08-21 | 25 | 0 |
| K090950 | BONE PLUS BCP | Megagen Implant Co., Ltd. | 2010-07-02 | 455 | 0 |
| K081302 | RESCUE EXTERNAL IMPLANT SYSTEM | Megagen Implant Co., Ltd. | 2008-08-15 | 99 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda