510(k) · Cleared
ClearedHealing Abutment, Cover 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 Feb 3, 2022 as substantially equivalent to K192436 (Dentium Co., Ltd., 2020) after a 321-day review. Its family tree reaches back 3 generations to 1994. 4 later devices descend from it.
- Decided
- Feb 3, 2022
- Review
- 321 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K931767 (1994). 4 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK931767 Astra Tech Implants-Dental SystemAstra Tech, Inc. · 1994
- 2 generations backK052957 Implantium ProstheticsDentium Co., Ltd. · 2006
- 1 generation backK192436 Healing Abutments and Cover ScrewsDentium Co., Ltd. · 2020
- This deviceK210826 Healing Abutment, Cover ScrewMegagen Implant Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK252585 ZENEX Implant System_R-SystemIzenimplant Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK253334 ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK230126 Dentis s-Clean Regular AbutmentDentis Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK230203 Dentis I-FIX AbutmentDentis Co., Ltd. · 2023
Most influential descendants
Showing 4 of 4 · See all- K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd. · 2026 · cites it directly1descendant
- K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd. · 2026 · 2 generations on0descendants
- K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd. · 2023 · cites it directly0descendants
- K230203Dentis I-FIX AbutmentDentis Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931767 | Astra Tech Implants-Dental System | Astra Tech, Inc. | 1994 | — |
| −2 | K052957 | Implantium Prosthetics | Dentium Co., Ltd. | 2006 | — |
| −1 | K192436 | Healing Abutments and Cover Screws | Dentium Co., Ltd. | 2020 | — |
| 0 (this device) | K210826 | Healing Abutment, Cover Screw | Megagen Implant Co., Ltd. | 2022 | — |
| +1 | K252585 | ZENEX Implant System_R-System | Izenimplant Co., Ltd. | 2026 | — |
| +2 | K253334 | ZENEX Implant System_Short (R-System) | Izenimplant Co., Ltd. | 2026 | — |
| +1 | K230126 | Dentis s-Clean Regular Abutment | Dentis Co., Ltd. | 2023 | — |
| +1 | K230203 | Dentis I-FIX Abutment | Dentis Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2026 | 2 | 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 30.7 · 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 |
|---|---|---|---|
| * | K192436 | Healing Abutments and Cover ScrewsSummary page 4…Code: NHA • Classification regulation: Class II, 21 CFR 872.3630 4. Predicate Device ▪ Primary Predicate Device: K192436 - Healing Abutments and Cover Screws ▪ Reference Device: K110955 – AnyRidge Internal Implant System… | 2020 |
| † | K110955 | Anyridge Internal Implant System | 2011 |
| † | K123988 | Anyonetm Internal Implant System | 2013 |
| † | K182448 | AnyRidge Octa 1 Implant System | 2019 |
| † | K181138 | IS-III active System | 2018 |
| † | K150537 | MiNi Internal Implant System | 2015 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 28 years and passes through 3 companies; a new generation was cleared every 12.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K252585 (Izenimplant Co., Ltd., 2026) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Prosthetics are intended for use as an aid in prosthetic rehabilitation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210826 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210826: Healing Abutment, Cover Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210826
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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