510(k) · Cleared
Clearedi-Sil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spident Co., Ltd. · ELW Material, Impression
Cleared on Sep 30, 2016 as substantially equivalent to K152766 (Dentkist, Inc., 2016) after a 94-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Sep 30, 2016
- Review
- 94 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K943574 (1994). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK943574 Capture Impression MaterialDentsply Intl. · 1994
- 4 generations backK970433 Aquasil Rigid Smart Wetting Impression MaterialDentsply Intl. · 1997
- 3 generations backK021413 Aquasil Ultra Rigid Smart Wetting Impression MaterialDentsply Intl. · 2002
- 2 generations backK103164 Vonflex Heavy, Vinflex LightVericom Co., Ltd. · 2010
- 1 generation backK152766 CharmFlexDentkist, Inc. · 2016
- This deviceK161774 i-SilSpident Co., Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K943574 | Capture Impression Material | Dentsply Intl. | 1994 | — |
| −4 | K970433 | Aquasil Rigid Smart Wetting Impression Material | Dentsply Intl. | 1997 | — |
| −3 | K021413 | Aquasil Ultra Rigid Smart Wetting Impression Material | Dentsply Intl. | 2002 | — |
| −2 | K103164 | Vonflex Heavy, Vinflex Light | Vericom Co., Ltd. | 2010 | — |
| −1 | K152766 | CharmFlex | Dentkist, Inc. | 2016 | — |
| 0 (this device) | K161774 | i-Sil | Spident Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 |
|---|---|---|---|
| * | K152766 | CharmFlexSummary page 4…ular - i-Sil Putty fast - i-Sil Putty regular - i-Sil Bite 3. The legally marketed device to which we are claiming equivalence K152766, Dentkist, Inc 4. Device description i-Sil is impression material. It has 5 types: Heavy, Medium, Light, Putty and Bite. 5.… | 2016 |
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 22 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K152766.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
- Impression material in a dual phase impression technique
- Precise duplication of models
- Capturing multiple unit impressions
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/K161774 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161774: i-Sil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161774
Report an extraction error
Are you the manufacturer?
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