510(k) · Cleared
ClearedSildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hrs Co., Ltd. · ELW Material, Impression
Cleared on Nov 28, 2018 as substantially equivalent to K882690 (3M Company, 1988) and 1 other predicate after a 162-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Nov 28, 2018
- Review
- 162 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K882690 (1988). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK882690 Imprint Vinyl Polysiloxane Impression Material3M Company · 1988
- This deviceK181604 Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent BiteHrs Co., Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K882690 | Imprint Vinyl Polysiloxane Impression Material | 3M Company | 1988 | — |
| 0 (this device) | K181604 | Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite | Hrs Co., Ltd. | 2018 | — |
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? (2)
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 |
|---|---|---|---|
| * | K882690 | Imprint Vinyl Polysiloxane Impression MaterialSummary page 4…me: impression material Panel: dental Product Code & Regulation: ELW / 872.3660 Predicate Device Information: K882690 3M Imprint K024034 Zhermack Occulfast Rock Device Description: Vinyl polysiloxane is an addition-reaction silicone elastomer (a… | 1988 |
| * | K024034 | Occlufast RockSummary page 4…impression material Panel: dental Product Code & Regulation: ELW / 872.3660 Predicate Device Information: K882690 3M Imprint K024034 Zhermack Occulfast Rock Device Description: Vinyl polysiloxane is an addition-reaction silicone elastomer (an addition silicone… | 2002 |
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?
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K882690.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
to obtain 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/K181604 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181604: Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181604
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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