510(k) · Cleared
ClearedImage Fast Set, Image Regular Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sybron Dental Specialties · ELW Material, Impression
Cleared on Aug 5, 2016 as substantially equivalent to K160441 (Kerr Corporation, 2016) after a 199-day review. Its family tree reaches back 2 generations to 2012. 1 later device descends from it.
- Decided
- Aug 5, 2016
- Review
- 199 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K121824 (2012). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK121824 Alginor Alginelle Type 1 and 2 Millenium Kromopan 1 and 2Lascod Spa · 2012
- 1 generation backK160441 Identic and KromaFaze Alginate Dental Impression MaterialsKerr Corporation · 2016
- This deviceK160097 Image Fast Set, Image Regular SetSybron Dental Specialties · 2016
- Descendant · cites it directly · 0 of its ownK253501 Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print…Vigodent Indústria E Comercio Ltda · 2025
Most influential descendants
Showing 1 of 1 · See all- K253501Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set -…Vigodent Indústria E Comercio Ltda · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K121824 | Alginor Alginelle Type 1 and 2 Millenium Kromopan 1 and 2 | Lascod Spa | 2012 | — |
| −1 | K160441 | Identic and KromaFaze Alginate Dental Impression Materials | Kerr Corporation | 2016 | — |
| 0 (this device) | K160097 | Image Fast Set, Image Regular Set | Sybron Dental Specialties | 2016 | — |
| +1 | K253501 | Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium… | Vigodent Indústria E Comercio Ltda | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K160441 | Identic and KromaFaze Alginate Dental Impression Materials Cleared while this submission was under review Summary page 4…te product lines are substantially equivalent to the legally marketed devices Identic Alginate and KromaFaze Alginate product lines cleared on June 30th, 2016 (K160441), product code ELW. 4. Description of Device: Alginate impression materials are elastic, irreversible hydrocolloid impress… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253501 | Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set -… | 2025 | 0 |
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 4 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K253501 (Vigodent Indústria E Comercio Ltda, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K160441.
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?
Image Alginate Dental Impression materials are irreversible hydrocolloids for dental impressions used by the dentist to take the anatomical data of the patient's mouth and subsequently realize a plaster mold useful to diagnose problems, define the required interventions and/or check their effectiveness. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160097 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160097: Image Fast Set, Image Regular Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160097
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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