510(k) · Cleared
ClearedHySil Plus Impression Materials
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osstem Implant Co., Ltd. · ELW Material, Impression
Cleared on Mar 18, 2021 as substantially equivalent to K192941 (Osstem Implant Co., Ltd., 2020) and 1 other predicate after a 70-day review. Its family tree reaches back 8 generations to 1994.
- Decided
- Mar 18, 2021
- Review
- 70 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K943574 (1994). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK943574 Capture Impression MaterialDentsply Intl. · 1994
- 7 generations backK973782 Aquasil XLV Smart Wetting Impression MaterialDentsply Intl. · 1997
- 6 generations backK021410 Aquasil Ultra XLV Smart Wetting Impression MaterialDentsply Intl. · 2002
- 5 generations backK082560 Panasil Impression Materials, Including Putty, Binetics, Tray…Kettenbach GmbH & Co. KG · 2008
- 4 generations backK133527 Suflex Putty, Suflex Heavy, Suflex Mono, Suflex LightOsstem Germany GmbH · 2014
- 3 generations backK151262 Hyflex Heavy, Hyflex Mono, Hyflex LightOsstem Implant Co., Ltd. · 2015
- 2 generations backK170736 HySil Impression MaterialsOsstem Implant Co., Ltd. · 2017
- 1 generation backK181236 HySil Impression MaterialsOsstem Implant Co., Ltd. · 2018
- This deviceK210041 HySil Plus Impression MaterialsOsstem Implant Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K943574 | Capture Impression Material | Dentsply Intl. | 1994 | — |
| −7 | K973782 | Aquasil XLV Smart Wetting Impression Material | Dentsply Intl. | 1997 | — |
| −6 | K021410 | Aquasil Ultra XLV Smart Wetting Impression Material | Dentsply Intl. | 2002 | — |
| −5 | K082560 | Panasil Impression Materials, Including Putty, Binetics, Tray, Monophase and… | Kettenbach GmbH & Co. KG | 2008 | — |
| −4 | K133527 | Suflex Putty, Suflex Heavy, Suflex Mono, Suflex Light | Osstem Germany GmbH | 2014 | — |
| −3 | K151262 | Hyflex Heavy, Hyflex Mono, Hyflex Light | Osstem Implant Co., Ltd. | 2015 | — |
| −2 | K170736 | HySil Impression Materials | Osstem Implant Co., Ltd. | 2017 | — |
| −1 | K181236 | HySil Impression Materials | Osstem Implant Co., Ltd. | 2018 | — |
| 0 (this device) | K210041 | HySil Plus Impression Materials | Osstem Implant Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K192941 | HySil Super Fast Impression MaterialsSummary page 4…assification Product Code : ELW 3. Predicated Device - Primary Predicate HySil Super Fast Impression Materials, Osstem Implant Co., Ltd. (K192941) HySil Heavy Plus Impression Materials, Osstem Implant Co., Ltd. (K181236) 4. Description HySil Heavy Plus,… | 2020 |
| * | K181236 | HySil Impression MaterialsSummary page 4…Predicate HySil Super Fast Impression Materials, Osstem Implant Co., Ltd. (K192941) HySil Heavy Plus Impression Materials, Osstem Implant Co., Ltd. (K181236) 4. Description HySil Heavy Plus, HySil Mono Plus, HySil Light Plus, HySil Heavy Plus Auto (hereinafter ref… | 2018 |
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 27 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 16 ancestors has a recall of any class.
- 1 other device also cites its predicate K192941.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
HySil Heavy Plus is to be used as heavy-bodied materials for: - One-step impression technique (simultaneous technique) using single or dual viscosities - Two-step impression technique using dual viscosities - Functional impressions HySil Mono Plus is to be used as a medium-bodied tray or syringeable impression material for: - Taking impressions over fixed/removable restorations and implants (i.e., transferring impression posts and bridge components) -…
Read the full statement (179 words)
HySil Heavy Plus is to be used as heavy-bodied materials for:
- One-step impression technique (simultaneous technique) using single or dual viscosities
- Two-step impression technique using dual viscosities
- Functional impressions
HySil Mono Plus is to be used as a medium-bodied tray or syringeable impression material for:
- Taking impressions over fixed/removable restorations and implants
(i.e., transferring impression posts and bridge components)
- Functional impressions
- Fabricating crown and bridgework or inlays
- Fabricating full or partial dentures
- Reline impressions
- Use in the simultaneous mixing technique as well as the putty-wash and triple tray
techniques
- Transferring root posts when fabricating posts and cores indirectly
HySil Light Plus is to be used as syringeable impression materials for:
- Two-step putty-wash impression technique
- One-step putty-wash impression technique
- Two-step impression technique using dual viscosities
- Reline impressions
- Fabricating full or partial dentures
HySil Heavy Plus Auto is to be used as heavy-bodied materials for:
- One-step impression technique (simultaneous technique) using single or dual viscosities
- Two-step impression technique using dual viscosities
- Functional impressions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210041 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210041: HySil Plus 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/K210041
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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