510(k) · Cleared
ClearedN1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osstem Implant Co., Ltd. · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Nov 28, 2023 as substantially equivalent to K051795 (Aribex, Inc., 2005) after a 145-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Nov 28, 2023
- Review
- 145 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K000061 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK000061 Minxray HF70D High Frequency Portable Dental X-Ray UnitMinxray, Inc. · 2000
- 2 generations backK021378 Portable HDX Intraoral X-RayDentalez Group · 2002 · Recalled
- 1 generation backK051795 Nomad Dental X-Ray SystemAribex, Inc. · 2005
- This deviceK232012 N1Osstem Implant Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
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 EHD? 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 EHD device
- #1 K260795 Hand-held Dental X-ray System (HyperLight-M)score 14.1 · 8 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 |
|---|---|---|---|
| * | K051795 | Nomad Dental X-Ray SystemSummary page 4…800 - Devce Classification : Class II - Classification Product Code : EHD - 510(k) number : K051795 4. Description - N1 is a portable dental X-ray imaging device powered by a rechargeable lithium polymer battery pack. I… | 2005 |
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 23 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 4 other devices also cite its predicate K051795.
How does its category compare?
All EHD devicesEHD Unit, X-Ray, Extraoral With Timer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · EHD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EHD
58in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EHD
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EHD
6in 2024
MAUDE reports naming product code EHD, 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 | 1 | — | 0 | 5 |
| 2008 | 5 | 49 | 0 | 6 |
| 2009 | 4 | 92 | 0 | 38 |
| 2010 | 4 | 268 | 3 | 47 |
| 2011 | 3 | 102 | 3 | 26 |
| 2012 | 2 | — | 0 | 22 |
| 2013 | 4 | 216 | 0 | 21 |
| 2014 | 3 | 107 | 1 | 20 |
| 2015 | 1 | — | 0 | 110 |
| 2016 | 2 | — | 1 | 63 |
| 2017 | 4 | 28 | 1 | 66 |
| 2018 | 5 | 30 | 0 | 21 |
| 2019 | 4 | 173 | 0 | 21 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 1 | — | 0 | 4 |
| 2022 | 8 | 58 | 0 | 4 |
| 2023 | 8 | 147 | 0 | 2 |
| 2024 | 7 | 58 | 0 | 6 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 6 | 128 | 0 | — |
What is it indicated for?
N1 is a dental portable X-ray imaging system that captures radiographic images for dental diagnosis using intraoral imaging sensors. Only trained and qualified dental practitioner or radiologist shall use N1 to diagnose and treat diseases related to the teeth, jaws, and/or other oral structures in adults and children.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232012 · printed Nov 3, 2026
Cite this page
510(k) Report. “K232012: N1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K232012
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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