510(k) · Cleared
ClearedDental Impression Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanchang Dental Bright Technology Co., Ltd. · ELW Material, Impression
Cleared on Jul 28, 2021 as substantially equivalent to K201483 (Zhengzhou Huaer Electro Optics Technology Co., Ltd., 2020) after a 76-day review. Its family tree reaches back 3 generations to 2011. 1 later device descends from it.
- Decided
- Jul 28, 2021
- Review
- 76 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K103346 (2011). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK103346 Delikit Putty, Delikit Heavy Body, Delikit Light BodySherpa Korea · 2011
- 2 generations backK152518 Vonflex S PuttyVericom Co., Ltd. · 2015
- 1 generation backK201483 Impression MaterialZhengzhou Huaer Electro Optics Technology Co., Ltd. · 2020
- This deviceK211489 Dental Impression MaterialNanchang Dental Bright Technology Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK221668 Dental Impression MaterialChemoment Materials Co.,Ltd · 2022
Most influential descendants
Showing 1 of 1 · See all- K221668Dental Impression MaterialChemoment Materials Co.,Ltd · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K103346 | Delikit Putty, Delikit Heavy Body, Delikit Light Body | Sherpa Korea | 2011 | — |
| −2 | K152518 | Vonflex S Putty | Vericom Co., Ltd. | 2015 | — |
| −1 | K201483 | Impression Material | Zhengzhou Huaer Electro Optics Technology Co., Ltd. | 2020 | — |
| 0 (this device) | K211489 | Dental Impression Material | Nanchang Dental Bright Technology Co., Ltd. | 2021 | — |
| +1 | K221668 | Dental Impression Material | Chemoment Materials Co.,Ltd | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 ELW? 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 ELW device
- #1 K254152 Dia-X Sil Light Bodyscore 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 |
|---|---|---|---|
| * | K201483 | Impression MaterialSummary page 4…Information Classification Name: Material, Impression Classification: Class II. Product code: ELW Regulation Number: 872.3660 Review Panel: Dental C. Predicate device: K201483 Impression Material Zhengzhou Huaer Electro Optics Technology Co., Ltd. D. Indications for use of the device: The Dental Impress… | 2020 |
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 |
|---|---|---|---|
| K221668 | Dental Impression Material | 2022 | 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 10 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K221668 (Chemoment Materials Co.,Ltd, 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · ELW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ELW
98in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ELW
3in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ELW
22in 2025
MAUDE reports naming product code ELW, 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 | 7 | 60 | 0 | 9 |
| 2008 | 11 | 30 | 0 | 17 |
| 2009 | 7 | 43 | 0 | 7 |
| 2010 | 5 | 88 | 1 | 16 |
| 2011 | 9 | 83 | 0 | 15 |
| 2012 | 7 | 87 | 1 | 14 |
| 2013 | 5 | 67 | 3 | 32 |
| 2014 | 11 | 122 | 0 | 35 |
| 2015 | 8 | 93 | 0 | 18 |
| 2016 | 7 | 166 | 3 | 15 |
| 2017 | 3 | 89 | 0 | 17 |
| 2018 | 5 | 126 | 0 | 14 |
| 2019 | 2 | — | 0 | 24 |
| 2020 | 4 | 99 | 0 | 8 |
| 2021 | 3 | 76 | 0 | 6 |
| 2022 | 7 | 60 | 0 | 9 |
| 2023 | 2 | — | 0 | 13 |
| 2024 | 3 | 98 | 0 | 3 |
| 2025 | 2 | — | 0 | 22 |
| 2026 | 3 | 268 | 0 | — |
What is it indicated for?
The Dental Impression Material is intended for use with all crowns, bridges, and orthodontic impression techniques to reproduce the structure of a patient’s teeth and gums.
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/K211489 · printed Nov 3, 2026
Cite this page
510(k) Report. “K211489: Dental Impression Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K211489
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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