510(k) · Cleared
ClearedK3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osstem Implant Co., Ltd. · EIA Unit, Operative Dental
Cleared on Sep 4, 2019 as substantially equivalent to K152830 (Osstem Implant Co., Ltd., 2017) after a 275-day review. Its family tree reaches back 3 generations to 1996. 7 later devices descend from it.
- Decided
- Sep 4, 2019
- Review
- 275 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K962071 (1996). 7 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK962071 Spirit S1/S2Pelton & Crane Co. · 1996
- 2 generations backK983242 Sirona C8 Dental Operative Unit with AccessoriesSirona Dental Systems GmbH · 1998
- 1 generation backK152830 K3Osstem Implant Co., Ltd. · 2017
- This deviceK183347 K3Osstem Implant Co., Ltd. · 2019
- Descendant · cites it directly · 1 of its ownK233921 Luvis Chair (LC700C)Dentis Co., Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK233805 K5Osstem Implant Co., Ltd. Chair Business · 2024
- Descendant · cites it directly · 1 of its ownK211556 N2Megagen Implant Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK251491 K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair Business · 2025
- Descendant · cites it directly · 0 of its ownK243130 Integral Dental UnitGuangdong Yadeng Medical Apparatus Co., Ltd., · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K233921Luvis Chair (LC700C)Dentis Co., Ltd. · 2024 · cites it directly1descendant
- K233805K5Osstem Implant Co., Ltd. Chair Business · 2024 · cites it directly1descendant
- K211556N2Megagen Implant Co., Ltd. · 2023 · cites it directly1descendant
- K251491K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair Business · 2025 · 2 generations on0descendants
- K243130Integral Dental UnitGuangdong Yadeng Medical Apparatus Co., Ltd., · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962071 | Spirit S1/S2 | Pelton & Crane Co. | 1996 | — |
| −2 | K983242 | Sirona C8 Dental Operative Unit with Accessories | Sirona Dental Systems GmbH | 1998 | — |
| −1 | K152830 | K3 | Osstem Implant Co., Ltd. | 2017 | — |
| 0 (this device) | K183347 | K3 | Osstem Implant Co., Ltd. | 2019 | — |
| +1 | K233921 | Luvis Chair (LC700C) | Dentis Co., Ltd. | 2024 | — |
| +1 | K233805 | K5 | Osstem Implant Co., Ltd. Chair Business | 2024 | — |
| +1 | K211556 | N2 | Megagen Implant Co., Ltd. | 2023 | — |
| +2 | K251491 | K5 Cart, K5 Mount, K5 Swing | Osstem Implant Company., Ltd. Chair Business | 2025 | — |
| +1 | K243130 | Integral Dental Unit | Guangdong Yadeng Medical Apparatus Co., Ltd., | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K152830 | K3Summary page 4…2.6640) - Product Code: EIA - Device Class: Class I III. Predicate Devices K3 (K152830) IV. Product Description A Dental Unit and Chair K3 (ver 1.2) is designed for dental treatment of children and… | 2017 |
What descends from it? (7)
4 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 23 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K233921 (Dentis Co., Ltd., 2024) has gone furthest, with 1 descendant of its own.
How does its category compare?
All EIA devicesEIA Unit, Operative Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
K3 is intended to supply power to and serve as a base for dental devices and accessories. This device 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K183347 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183347: K3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183347
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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