510(k) · Cleared
ClearedDental Alginate Impression Material W/Anti. Addi.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · ELW Material, Impression
Cleared on Mar 17, 1989 after a 186-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 15 later devices descend from it.
- Decided
- Mar 17, 1989
- Review
- 186 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 2 citing it directly.
- This deviceK883842 Dental Alginate Impression Material W/Anti. Addi.Dentsply Intl. · 1989
- Descendant · cites it directly · 13 of its ownK952614 Jeltrate Plus Antimicrobial Impr. MaterialDentsply Intl. · 1996
- Descendant · 2 generations on · 12 of its ownK082943 Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc. · 2009
- Descendant · 3 generations on · 7 of its ownK092715 Iroot BP PlusInnovative Bioceramix, Inc. · 2009
- Descendant · 3 generations on · 3 of its ownK180185 Bio-C RepairAngelus Industria DE Produtos Odontologicos S/A · 2018
- Descendant · 3 generations on · 2 of its ownK102867 Iroot FSInnovative Bioceramix, Inc. · 2010
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K952614Jeltrate Plus Antimicrobial Impr. MaterialDentsply Intl. · 1996 · cites it directly13descendants
- K082943Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc. · 2009 · 2 generations on12descendants
- K092715Iroot BP PlusInnovative Bioceramix, Inc. · 2009 · 3 generations on7descendants
- K180185Bio-C RepairAngelus Industria DE Produtos Odontologicos S/A · 2018 · 3 generations on3descendants
- K102867Iroot FSInnovative Bioceramix, Inc. · 2010 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K883842 | Dental Alginate Impression Material W/Anti. Addi. | Dentsply Intl. | 1989 | — |
| +1 | K952614 | Jeltrate Plus Antimicrobial Impr. Material | Dentsply Intl. | 1996 | — |
| +2 | K082943 | Iroot BP, Model Irbp 4609 | Innovative Bioceramix, Inc. | 2009 | — |
| +3 | K092715 | Iroot BP Plus | Innovative Bioceramix, Inc. | 2009 | — |
| +3 | K180185 | Bio-C Repair | Angelus Industria DE Produtos Odontologicos S/A | 2018 | — |
| +3 | K102867 | Iroot FS | Innovative Bioceramix, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (15)
See all 152 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, K952614 (Dentsply Intl., 1996) has gone furthest, with 13 descendants 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.
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 | — |
https://510kreport.com/device/K883842 · printed Nov 6, 2026
Cite this page
510(k) Report. “K883842: Dental Alginate Impression Material W/Anti. Addi..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K883842
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026