510(k) · Cleared
ClearedSuper-Dent Alginate,Normal Set, Fast Set,Super Deluxe Dustless Alginate, Normal Set, Deluxe Dutless Alginate, Fast Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
S.S. White Mfg., Ltd. · ELW Material, Impression
Cleared on Apr 4, 1997 as substantially equivalent to K883842 (Dentsply Intl., 1989) after a 106-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Apr 4, 1997
- Review
- 106 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K883842 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK883842 Dental Alginate Impression Material W/Anti. Addi.Dentsply Intl. · 1989
- This deviceK965083 Super-Dent Alginate,Normal Set, Fast Set,Super Deluxe Dustless…S.S. White Mfg., Ltd. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K883842 | Dental Alginate Impression Material W/Anti. Addi. | Dentsply Intl. | 1989 | — |
| 0 (this device) | K965083 | Super-Dent Alginate,Normal Set, Fast Set,Super Deluxe Dustless Alginate… | S.S. White Mfg., Ltd. | 1997 | — |
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 |
|---|---|---|---|
| * | K883842 | Dental Alginate Impression Material W/Anti. Addi.Summary page 1…e, Fast set COMMON NAME: Alginate impression material CLASSIFICATION NAME: Material, All, Impression EQUIVALENT TO: Dental Alginate Impression Material; 510(k) number K883842 Marketed by Dentsply as JELTRATE in fast and regular set versions DESCRIPTION: These materials consist of powders which, when… | 1989 |
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 K883842.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
These materials are intended for use in taking impressions of oral tissues for preparation of orthodontic prostheses and to create study models required in designing and fitting of such devices.
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/K965083 · printed Nov 5, 2026
Cite this page
510(k) Report. “K965083: Super-Dent Alginate,Normal Set, Fast Set,Super Deluxe Dustless Alginate, Normal Set, Deluxe Dutless Alginate, Fast Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K965083
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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