510(k) · Cleared
ClearedMegaGen Dental Implant Abutment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Megagen Implant Co., Ltd. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jan 13, 2025 as substantially equivalent to K233450 (Megagen Implant Co., Ltd., 2024) after a 186-day review. Its family tree reaches back 10 generations to 1995.
- Decided
- Jan 13, 2025
- Review
- 186 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K944964 (1995). 62 ancestors in all, the oldest K874590 (1988). No later device cites it as a predicate yet.
- Root · 10 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 6 generations between
- 3 generations backK070562 EZ Plus Implant SystemMegagen Co., Ltd. · 2007
- 2 generations backK110955 Anyridge Internal Implant SystemMegagen Co., Ltd. · 2011
- 1 generation backK233450 MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary…Megagen Implant Co., Ltd. · 2024
- This deviceK242030 MegaGen Dental Implant AbutmentMegagen Implant Co., Ltd. · 2025
Show all 10 generations
- Root · 10 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 9 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 8 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 7 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 6 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 5 generations backK041655 Bio Plant System (Implants and Abutments)Cowellmedi Co., Ltd. · 2004
- 4 generations backK052369 Exfeel Implant SystemMegagen Co., Ltd. · 2006
- 3 generations backK070562 EZ Plus Implant SystemMegagen Co., Ltd. · 2007
- 2 generations backK110955 Anyridge Internal Implant SystemMegagen Co., Ltd. · 2011
- 1 generation backK233450 MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary…Megagen Implant Co., Ltd. · 2024
- This deviceK242030 MegaGen Dental Implant AbutmentMegagen Implant Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −9 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −8 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −7 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −6 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −5 | K041655 | Bio Plant System (Implants and Abutments) | Cowellmedi Co., Ltd. | 2004 | — |
| −4 | K052369 | Exfeel Implant System | Megagen Co., Ltd. | 2006 | — |
| −3 | K070562 | EZ Plus Implant System | Megagen Co., Ltd. | 2007 | — |
| −2 | K110955 | Anyridge Internal Implant System | Megagen Co., Ltd. | 2011 | — |
| −1 | K233450 | MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment… | Megagen Implant Co., Ltd. | 2024 | — |
| 0 (this device) | K242030 | MegaGen Dental Implant Abutment | Megagen Implant Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 10 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 5 | 0 |
| 2001 | 2 | 0 |
| 2002 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NHA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K233450 | MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary…Summary page 5…Product Code: NHA • Classification regulation: Class II, 21 CFR 872.3630 4. Predicate Device • Primary Predicate Device: K233450 MegaGen Dental Implant Abutment • Reference Devices: K110955 AnyRidge Internal Implant System K123988 A… | 2024 |
| † | K110955 | Anyridge Internal Implant System | 2011 |
| † | K123988 | Anyonetm Internal Implant System | 2013 |
| † | K182448 | AnyRidge Octa 1 Implant System | 2019 |
| † | K203554 | AnyOne External Implant System | 2021 |
| † | K203808 | Multi-unit Abutment, Multi-unit Angled Abutment | 2021 |
| † | K230618 | MegaGen Dental Implant Systems Portfolio - MR Conditional | 2023 |
| † | K231967 | ARi ExCon Implant System | 2023 |
| † | K220562 | TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment | 2022 |
| † | K210161 | AnyOne Onestage Implant System | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 62 ancestors have a recall of any class.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
MegaGen Dental Implant Abutment is intended to be surgically placed in the maxillary or mandibular areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function.
All digitally designed abutments for use with TiGEN Abutment and ZrGEN Abutment are intended to be sent to a MegaGen validated milling center for manufacture
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242030 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242030: MegaGen Dental Implant Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242030
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026