510(k) · Cleared
ClearedAccu-Dent XD Tray, Accu-Dent XD Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivoclar Vivadent, Inc. · ELW Material, Impression
Cleared on Apr 3, 2015 as substantially equivalent to K043131 (Zhermack S.P.A., 2004) and 1 other predicate after a 107-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Apr 3, 2015
- Review
- 107 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K981091 (1998). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK981091 Neocolloid, OrthoprintZhermack S.P.A. · 1998
- This deviceK143575 Accu-Dent XD Tray, Accu-Dent XD SyringeIvoclar Vivadent, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981091 | Neocolloid, Orthoprint | Zhermack S.P.A. | 1998 | — |
| 0 (this device) | K143575 | Accu-Dent XD Tray, Accu-Dent XD Syringe | Ivoclar Vivadent, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 |
|---|---|---|---|
| * | K043131 | TorpicalginSummary page 4…nt® XD Classification Name: Material, Impression (872.3660) (Classification Code ELW) Predicate Device: Tropicalgin (K043131) & Neocolloid (K981091) by Zhermack sPA Device Description: Accu-Dent XD is a two-part Alginate impression system inte… | 2004 |
| * | K981091 | Neocolloid, OrthoprintSummary page 4…Name: Material, Impression (872.3660) (Classification Code ELW) Predicate Device: Tropicalgin (K043131) & Neocolloid (K981091) by Zhermack sPA Device Description: Accu-Dent XD is a two-part Alginate impression system intended… | 1998 |
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?
- None of the 2 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. 2015, 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?
The Accu-Dent XD impression materials are recommended for used to create highly
detailed impressions of the hard and soft tissues of the oral cavity includin the following
list of indications:
e Complete and partial denture impressions
Opposing models for fixed and removable prosthesis
Study Model
Temporary crown & Bridge impressions
Whitening Trays
Mouth Guards
Orthodontic Impressions
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/K143575 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143575: Accu-Dent XD Tray, Accu-Dent XD Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143575
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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