510(k) · Cleared
ClearedMegaGen 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
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 22, 2024 as substantially equivalent to K110955 (Megagen Co., Ltd., 2011) after a 94-day review. Its family tree reaches back 9 generations to 1995. 1 later device descends from it.
- Decided
- Jan 22, 2024
- Review
- 94 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K944964 (1995). 61 ancestors in all, the oldest K874590 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 5 generations between
- 3 generations backK052369 Exfeel Implant SystemMegagen Co., Ltd. · 2006
- 2 generations backK070562 EZ Plus Implant SystemMegagen Co., Ltd. · 2007
- 1 generation backK110955 Anyridge Internal Implant SystemMegagen Co., Ltd. · 2011
- This deviceK233450 MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary…Megagen Implant Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK242030 MegaGen Dental Implant AbutmentMegagen Implant Co., Ltd. · 2025
Show all 9 generations
- Root · 9 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 8 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 7 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 6 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 5 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 4 generations backK041655 Bio Plant System (Implants and Abutments)Cowellmedi Co., Ltd. · 2004
- 3 generations backK052369 Exfeel Implant SystemMegagen Co., Ltd. · 2006
- 2 generations backK070562 EZ Plus Implant SystemMegagen Co., Ltd. · 2007
- 1 generation backK110955 Anyridge Internal Implant SystemMegagen Co., Ltd. · 2011
- This deviceK233450 MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary…Megagen Implant Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K242030MegaGen Dental Implant AbutmentMegagen Implant Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −8 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −7 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −6 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −5 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −4 | K041655 | Bio Plant System (Implants and Abutments) | Cowellmedi Co., Ltd. | 2004 | — |
| −3 | K052369 | Exfeel Implant System | Megagen Co., Ltd. | 2006 | — |
| −2 | K070562 | EZ Plus Implant System | Megagen Co., Ltd. | 2007 | — |
| −1 | K110955 | Anyridge Internal Implant System | Megagen Co., Ltd. | 2011 | — |
| 0 (this device) | K233450 | MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment… | Megagen Implant Co., Ltd. | 2024 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K110955 | Anyridge Internal Implant SystemSummary page 5…de: NHA • Classification regulation: Class II, 21 CFR 872.3630 4. Predicate Device • Primary Predicate Device: K110955 AnyRidge Internal Implant System • Reference Devices: K122231 XPEED AnyRidge Internal Implant System… | 2011 |
| † | K122231 | Xpeed Any Ridge Internal Implant System | 2012 |
| † | K123988 | Anyonetm Internal Implant System | 2013 |
| † | K182448 | AnyRidge Octa 1 Implant System | 2019 |
| † | K203808 | Multi-unit Abutment, Multi-unit Angled Abutment | 2021 |
| † | K210826 | Healing Abutment, Cover Screw | 2022 |
| † | K211812 | BLUEDIAMOND IMPLANT, Abutment Screw | 2023 |
| † | K220562 | TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment | 2022 |
| † | K103280 | Bhdental Implant System | 2011 |
| † | K133377 | Nobelprocera Angulated Screw Channel Abutment Replace | 2014 |
| † | K231967 | ARi ExCon Implant System | 2023 |
| † | K203554 | AnyOne External Implant System | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242030 | MegaGen Dental Implant Abutment | 2025 | 0 |
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 29 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 61 ancestors have a recall of any class.
- Of its descendants, K242030 (Megagen Implant Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K110955.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 patients chewing function.
All digitally designed abutments for use with 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/K233450 · printed Nov 5, 2026
Cite this page
510(k) Report. “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.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233450
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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