510(k) · Cleared
ClearedHydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204);
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vigodent Indústria E Comercio Ltda · ELW Material, Impression
Cleared on Oct 31, 2025 as substantially equivalent to K160097 (Sybron Dental Specialties, 2016) and 1 other predicate after a 1-day review. Its family tree reaches back 3 generations to 2012.
- Decided
- Oct 31, 2025
- Review
- 1 day
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K121824 (2012). No later device cites it as a predicate yet.
- Root · 3 generations backK121824 Alginor Alginelle Type 1 and 2 Millenium Kromopan 1 and 2Lascod Spa · 2012
- 2 generations backK160441 Identic and KromaFaze Alginate Dental Impression MaterialsKerr Corporation · 2016
- 1 generation backK160097 Image Fast Set, Image Regular SetSybron Dental Specialties · 2016
- This deviceK253501 Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print…Vigodent Indústria E Comercio Ltda · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K121824 | Alginor Alginelle Type 1 and 2 Millenium Kromopan 1 and 2 | Lascod Spa | 2012 | — |
| −2 | K160441 | Identic and KromaFaze Alginate Dental Impression Materials | Kerr Corporation | 2016 | — |
| −1 | K160097 | Image Fast Set, Image Regular Set | Sybron Dental Specialties | 2016 | — |
| 0 (this device) | K253501 | Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium… | Vigodent Indústria E Comercio Ltda | 2025 | — |
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 |
|---|---|---|---|
| * | K160097 | Image Fast Set, Image Regular SetSummary page 5…OCIATED PRODUCT CODES ARE AR | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K160097 Image Alginate ELW K160441 KromaFaze Alginate ELW Device Description Summary 21 CFR 807.92(a)(4) Device Description - Principl… | 2016 |
| * | K160441 | Identic and KromaFaze Alginate Dental Impression MaterialsSummary page 5…| Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K160097 Image Alginate ELW K160441 KromaFaze Alginate ELW Device Description Summary 21 CFR 807.92(a)(4) Device Description - Principle of Operation The Vigodent… | 2016 |
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 13 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
Chroma Print Premium is indicated for total or partial impressions of dentate or edentulous mouths in the fabrication of complete and partial removable dentures, orthodontic study models, and impressions for the manufacture of single and multiple restorations, crowns, and fixed bridges. Hydro Print Premium is indicated for total or partial impressions of dentate or edentulous mouths in the fabrication of complete and partial removable dentures…
Read the full statement (203 words)
Chroma Print Premium is indicated for total or partial impressions of dentate or edentulous mouths in the fabrication of complete and partial removable dentures, orthodontic study models, and impressions for the manufacture of single and multiple restorations, crowns, and fixed bridges.
Hydro Print Premium is indicated for total or partial impressions of dentate or edentulous mouths in the fabrication of complete and partial removable dentures, orthodontic study models, and impressions for the manufacture of single and multiple restorations, crowns, and fixed bridges.
Perfil Pro is indicated for total or partial impressions of dentate and edentulous mouths in the fabrication of complete and partial removable dentures, orthodontic study models, and impressions for the manufacture of single and multiple restorations, crowns, and fixed bridges.
Perfil Pro Chroma is indicated for total or partial impressions of dentate and edentulous mouths in the fabrication of complete and partial removable dentures, orthodontic study models, and impressions for the manufacture of single and multiple restorations, crowns, and fixed bridges.
Perfil Pro+ is indicated for total or partial impressions of dentate and edentulous mouths in the fabrication of complete and partial removable dentures, orthodontic study models, and impressions for the manufacture of single and multiple restorations, crowns, and fixed bridges.
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/K253501 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253501: Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204);.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253501
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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