510(k) · Cleared
ClearedBonasil a+ Impression Materials
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dmp, Ltd. · ELW Material, Impression
Cleared on Jan 13, 2011 after a 106-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Jan 13, 2011
- Review
- 106 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK102836 Bonasil a+ Impression MaterialsDmp, Ltd. · 2011
- Descendant · cites it directly · 1 of its ownK152180 PEAKNeosil Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK180565 Peak NS033CF, Peak NS017CFNeosil Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK143382 DentiAnn Smart SilSeilglobal Co., Ltd. · 2015
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K102836 | Bonasil a+ Impression Materials | Dmp, Ltd. | 2011 | — |
| +1 | K152180 | PEAK | Neosil Co., Ltd. | 2015 | — |
| +2 | K180565 | Peak NS033CF, Peak NS017CF | Neosil Co., Ltd. | 2018 | — |
| +1 | K143382 | DentiAnn Smart Sil | Seilglobal Co., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2018 | 1 | 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? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K152180 (Neosil Co., Ltd., 2015) has gone furthest, with 1 descendant 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?
The Bonasil At Impression Materials are intended to: - be placed on an impression tray (or injected directly into the mouth, depending on the technique and device) and used to reproduce the structure of a patent's teeth and gums; - provide models for study and for production of restorative prosthetics devices; *BONASIL At Putty (putty normal set, putty fast set, putty soft, putty extra hard, lab putty) is to be used as a preliminary material for: -Two…
Read the full statement (310 words)
The Bonasil At Impression Materials are intended to:
- be placed on an impression tray (or injected directly into the mouth, depending on the technique and device) and used to reproduce the structure of a patent's teeth and gums;
- provide models for study and for production of restorative prosthetics devices;
*BONASIL At Putty (putty normal set, putty fast set, putty soft, putty extra hard, lab 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
*BONASIL A Heavy (heavy normal set, heavy fast set) 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
*BONASIL A* Monophase (monophase normal set, manophase fast set) is to be used as* a semi-heavy body material for:
-Single step putty/wash technique
-Functional peripheries
-Crown/bridge work
-Inlays, onlays
*BONASIL A* Regular (regular normal set, regular fast set) is to be used as a medium body material for:
-Two step putty/wash technique
-Single step putty/wash technique
-Functional peripheries
-Reline impressions
-Crown/bridge work
-Inlays, onlays
*BONASIL Ai Light (light normal set, light fast set) 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
*BONASIL A* Bonabite (bonabite fast set) 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
-An optical registration of occlusal data for CAD/CAM/CIM systems
*BONASIL A' Alginate free (normal set, fast set) is an alternative to traditional alginate materials and is suitable for
-Preliminary impressions
-Anatomic models
-Fabricating temporary crowns and bridges
-Opposing dentition
-Fabricating simple removable prosthetic restorations
-Orthodontic work
-Case study models
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K102836 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102836: Bonasil a+ Impression Materials.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102836
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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