510(k) · Cleared
ClearedWiedent Estetic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xpdent Corp · ELM Denture, Plastic, Teeth
Cleared on Jun 7, 2006 after a 26-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Jun 7, 2006
- Review
- 26 days
- Class
- Class II
- Product code
- ELM
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK061337 Wiedent EsteticXpdent Corp · 2006
- Descendant · cites it directly · 2 of its ownK070591 Replica, Ortolux Top, Odipal, Odilux, Odident, Vitacrilic, Nature's…Union Dental S.A./Unidesa.Odi · 2007
- Descendant · cites it directly · 1 of its ownK101029 Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, Maist and Kaitong/Royal…Huge Dental Material Co., Ltd. · 2010
- Descendant · 2 generations on · 0 of its ownK122955 Dentavit, Monarch, Acrotone, Senator, DentoriumWright Health Group, Ltd. · 2013
Most influential descendants
Showing 3 of 3 · See all- K070591Replica, Ortolux Top, Odipal, Odilux, Odident, Vitacrilic, Nature's Best, Dental Acrylic…Union Dental S.A./Unidesa.Odi · 2007 · cites it directly2descendants
- K101029Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, Maist and Kaitong/Royal Synthetic Polymer TeethHuge Dental Material Co., Ltd. · 2010 · cites it directly1descendant
- K122955Dentavit, Monarch, Acrotone, Senator, DentoriumWright Health Group, Ltd. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061337 | Wiedent Estetic | Xpdent Corp | 2006 | — |
| +1 | K070591 | Replica, Ortolux Top, Odipal, Odilux, Odident, Vitacrilic, Nature's Best… | Union Dental S.A./Unidesa.Odi | 2007 | — |
| +1 | K101029 | Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, Maist and Kaitong/Royal Synthetic… | Huge Dental Material Co., Ltd. | 2010 | — |
| +2 | K122955 | Dentavit, Monarch, Acrotone, Senator, Dentorium | Wright Health Group, Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ELM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
2 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, K070591 (Union Dental S.A./Unidesa.Odi, 2007) has gone furthest, with 2 descendants of its own.
How does its category compare?
All ELM devicesELM Denture, Plastic, Teeth: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ELM
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · ELM
82in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ELM
No recall names ELM since 2007.
Adverse event reports per year · ELM
1in 2025
MAUDE reports naming product code ELM, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 125 | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 5 | 82 | 0 | 4 |
| 2013 | 2 | — | 0 | 43 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Acrylic teeth to be used for construction of full and partial dentures by a dental professional. Dentures are removable, not implanted in patients' mouths.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K061337 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061337: Wiedent Estetic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061337
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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