510(k) · Cleared
ClearedDentiAnn Smart Sil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seilglobal Co., Ltd. · ELW Material, Impression
Cleared on Feb 23, 2015 as substantially equivalent to K102836 (Dmp, Ltd., 2011) after a 90-day review. Its family tree reaches back 1 generation to 2011.
- Decided
- Feb 23, 2015
- Review
- 90 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K102836 (2011). No later device cites it as a predicate yet.
- Root · 1 generation backK102836 Bonasil a+ Impression MaterialsDmp, Ltd. · 2011
- This deviceK143382 DentiAnn Smart SilSeilglobal Co., Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K102836 | Bonasil a+ Impression Materials | Dmp, Ltd. | 2011 | — |
| 0 (this device) | K143382 | DentiAnn Smart Sil | Seilglobal Co., Ltd. | 2015 | — |
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 |
|---|---|---|---|
| * | K102836 | Bonasil a+ Impression MaterialsSummary page 4…Classification: Class II, 21 CFR 872.3660 Classification Product Code: ELW 4. Predicate Device: BONASIL A+ by DMP, Limited (K102836) Page 21 of 66 5. Device Description: DentiAnn Smart Sil is… | 2011 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K102836.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
DentiAnn Light-body is to be used as a light body material for: ▪ Two step putty/wash technique ▪ Single step putty/wash technique ▪ Functional peripheries ▪ Reline impressions ▪ Crown/bridge work ▪ Inlays, Onlays DentiAnn Heavy-body is to be used as a heavy body material for: ▪ Two step putty/wash technique ▪ Single step putty/wash technique ▪ Functional peripheries ▪ Crown/bridge work ▪ Inlays, Onlays SmartSil-Putty is to be used as a preliminary…
Read the full statement (132 words)
DentiAnn Light-body is to be used as a light body material for:
▪ Two step putty/wash technique
▪ Single step putty/wash technique
▪ Functional peripheries
▪ Reline impressions
▪ Crown/bridge work
▪ Inlays, Onlays
DentiAnn Heavy-body is to be used as a heavy body material for:
▪ Two step putty/wash technique
▪ Single step putty/wash technique
▪ Functional peripheries
▪ Crown/bridge work
▪ Inlays, Onlays
SmartSil-Putty is to be used as a preliminary material for:
▪ Two step putty/wash technique
▪ Single step putty/wash technique
▪ Functional peripheries
▪ Crown/bridge work
▪ Inlays, Onlays
SmartSil-Bite is to be used as a light body material for:
▪ Making accurate occlusal registrations
▪ Standards bite registrations in the end bite position.
▪ Key material for needle point registration.
▪ Production of small model segments
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143382 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143382: DentiAnn Smart Sil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143382
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