510(k) · Cleared
ClearedN2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Megagen Implant Co., Ltd. · EIA Unit, Operative Dental
Cleared on Apr 5, 2023 as substantially equivalent to K183347 (Osstem Implant Co., Ltd., 2019) after a 686-day review. Its family tree reaches back 4 generations to 1996. 1 later device descends from it.
- Decided
- Apr 5, 2023
- Review
- 686 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K962071 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK962071 Spirit S1/S2Pelton & Crane Co. · 1996
- 3 generations backK983242 Sirona C8 Dental Operative Unit with AccessoriesSirona Dental Systems GmbH · 1998
- 2 generations backK152830 K3Osstem Implant Co., Ltd. · 2017
- 1 generation backK183347 K3Osstem Implant Co., Ltd. · 2019
- This deviceK211556 N2Megagen Implant Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK240754 N2Megagen Implant Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K240754N2Megagen Implant Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K962071 | Spirit S1/S2 | Pelton & Crane Co. | 1996 | — |
| −3 | K983242 | Sirona C8 Dental Operative Unit with Accessories | Sirona Dental Systems GmbH | 1998 | — |
| −2 | K152830 | K3 | Osstem Implant Co., Ltd. | 2017 | — |
| −1 | K183347 | K3 | Osstem Implant Co., Ltd. | 2019 | — |
| 0 (this device) | K211556 | N2 | Megagen Implant Co., Ltd. | 2023 | — |
| +1 | K240754 | N2 | Megagen Implant Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 EIA? 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 EIA device
- #1 K231845 Dental unit Model: Marescore 14.4 · 6 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 |
|---|---|---|---|
| * | K183347 | K3Summary page 4…Product Code: EIA Regulation number: 21 CFR 872.6640 Device class: I 4. Predicate Device 510(k) number: K183347 Product name: K3 5. Description ▪ General The N2 is a dental treatment unit tested i… | 2019 |
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 |
|---|---|---|---|
| K240754 | N2 | 2024 | 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 27 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K240754 (Megagen Implant Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K183347.
How does its category compare?
All EIA devicesEIA Unit, Operative Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · EIA
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EIA
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EIA
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EIA
47in 2025
MAUDE reports naming product code EIA, 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 | 3 | 90 | 0 | 0 |
| 2008 | 6 | 72 | 0 | 0 |
| 2009 | 3 | 109 | 0 | 0 |
| 2010 | 3 | 270 | 0 | 2 |
| 2011 | 5 | 150 | 0 | 3 |
| 2012 | 2 | — | 1 | 7 |
| 2013 | 2 | — | 1 | 6 |
| 2014 | 2 | — | 0 | 255 |
| 2015 | 7 | 214 | 0 | 452 |
| 2016 | 4 | 182 | 0 | 151 |
| 2017 | 1 | — | 0 | 64 |
| 2018 | 2 | — | 0 | 73 |
| 2019 | 2 | — | 0 | 68 |
| 2020 | 1 | — | 0 | 48 |
| 2021 | 0 | — | 0 | 49 |
| 2022 | 3 | 265 | 0 | 44 |
| 2023 | 3 | 686 | 0 | 53 |
| 2024 | 3 | 251 | 0 | 53 |
| 2025 | 7 | 178 | 0 | 47 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
N2 is intended to supply power to and serve as a base for dental devices and accessories. This includes a dental chair and is intended for use in the dental clinic environment and is designed for use by trained dental professionals, dentists and/or dental assistants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211556 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211556: N2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211556
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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