510(k) · Cleared
ClearedDelikit Putty, Delikit Heavy Body, Delikit Light Body
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sherpa Korea · ELW Material, Impression
Cleared on Feb 11, 2011 after an 88-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Feb 11, 2011
- Review
- 88 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK103346 Delikit Putty, Delikit Heavy Body, Delikit Light BodySherpa Korea · 2011
- Descendant · cites it directly · 4 of its ownK152518 Vonflex S PuttyVericom Co., Ltd. · 2015
- Descendant · 2 generations on · 2 of its ownK201483 Impression MaterialZhengzhou Huaer Electro Optics Technology Co., Ltd. · 2020
- Descendant · 3 generations on · 1 of its ownK211489 Dental Impression MaterialNanchang Dental Bright Technology Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK222741 DENU Light Body (Regular, Fast), DENU Heavy Body (Regular, Fast)…Hdi, Inc. · 2022
- Descendant · 4 generations on · 0 of its ownK221668 Dental Impression MaterialChemoment Materials Co.,Ltd · 2022
Most influential descendants
Showing 5 of 5 · See all- K152518Vonflex S PuttyVericom Co., Ltd. · 2015 · cites it directly4descendants
- K201483Impression MaterialZhengzhou Huaer Electro Optics Technology Co., Ltd. · 2020 · 2 generations on2descendants
- K211489Dental Impression MaterialNanchang Dental Bright Technology Co., Ltd. · 2021 · 3 generations on1descendant
- K222741DENU Light Body (Regular, Fast), DENU Heavy Body (Regular, Fast), DENU Putty Set…Hdi, Inc. · 2022 · 2 generations on0descendants
- K221668Dental Impression MaterialChemoment Materials Co.,Ltd · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K103346 | Delikit Putty, Delikit Heavy Body, Delikit Light Body | Sherpa Korea | 2011 | — |
| +1 | K152518 | Vonflex S Putty | Vericom Co., Ltd. | 2015 | — |
| +2 | K201483 | Impression Material | Zhengzhou Huaer Electro Optics Technology Co., Ltd. | 2020 | — |
| +3 | K211489 | Dental Impression Material | Nanchang Dental Bright Technology Co., Ltd. | 2021 | — |
| +2 | K222741 | DENU Light Body (Regular, Fast), DENU Heavy Body (Regular, Fast), DENU Putty… | Hdi, Inc. | 2022 | — |
| +4 | K221668 | Dental Impression Material | Chemoment Materials Co.,Ltd | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152518 | Vonflex S Putty | 2015 | 4 |
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?
- Of its descendants, K152518 (Vericom Co., Ltd., 2015) has gone furthest, with 4 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. 2011, 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?
Delikit is an addition-cure vinyl polysiloxane dental impression material that is used for all crown and
bridge, edentulous, orthodontic and implant impression techniques.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K103346 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103346: Delikit Putty, Delikit Heavy Body, Delikit Light Body.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103346
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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