510(k) · Cleared
ClearedAcry Pan, Vipi Dent Plus, Biolux, Biolux V, New Dent, Dentoluxx, Vipi Dent N.H., Vipi Dent V
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dental Vipi Ltda · ELM Denture, Plastic, Teeth
Cleared on Oct 3, 2002 after a 79-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it.
- Decided
- Oct 3, 2002
- Review
- 79 days
- Class
- Class II
- Product code
- ELM
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 4 citing it directly.
- This deviceK022300 Acry Pan, Vipi Dent Plus, Biolux, Biolux V, New Dent, Dentoluxx…Dental Vipi Ltda · 2002
- Descendant · cites it directly · 7 of its ownK030588 Artegral and Polystar SelectionMerz Dental GmbH · 2003
- Descendant · 2 generations on · 3 of its ownK060507 Valplast Yamahachi TeethValplast Intl. 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 · 2 generations on · 1 of its ownK134015 M-PM-DiscMerz Dental GmbH · 2014
- Descendant · cites it directly · 1 of its ownK101029 Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, Maist and Kaitong/Royal…Huge Dental Material Co., Ltd. · 2010
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K030588Artegral and Polystar SelectionMerz Dental GmbH · 2003 · cites it directly7descendants
- K060507Valplast Yamahachi TeethValplast Intl. Corp. · 2006 · 2 generations on3descendants
- K070591Replica, Ortolux Top, Odipal, Odilux, Odident, Vitacrilic, Nature's Best, Dental Acrylic…Union Dental S.A./Unidesa.Odi · 2007 · cites it directly2descendants
- K134015M-PM-DiscMerz Dental GmbH · 2014 · 2 generations on1descendant
- K101029Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, Maist and Kaitong/Royal Synthetic Polymer TeethHuge Dental Material Co., Ltd. · 2010 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022300 | Acry Pan, Vipi Dent Plus, Biolux, Biolux V, New Dent, Dentoluxx, Vipi Dent… | Dental Vipi Ltda | 2002 | — |
| +1 | K030588 | Artegral and Polystar Selection | Merz Dental GmbH | 2003 | — |
| +2 | K060507 | Valplast Yamahachi Teeth | Valplast Intl. Corp. | 2006 | — |
| +1 | K070591 | Replica, Ortolux Top, Odipal, Odilux, Odident, Vitacrilic, Nature's Best… | Union Dental S.A./Unidesa.Odi | 2007 | — |
| +2 | K134015 | M-PM-Disc | Merz Dental GmbH | 2014 | — |
| +1 | K101029 | Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, Maist and Kaitong/Royal Synthetic… | Huge Dental Material Co., Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 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? (8)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030588 | Artegral and Polystar Selection | 2003 | 7 |
| K070591 | Replica, Ortolux Top, Odipal, Odilux, Odident, Vitacrilic, Nature's Best, Dental Acrylic… | 2007 | 2 |
| K101029 | Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, Maist and Kaitong/Royal Synthetic Polymer Teeth | 2010 | 1 |
| K122955 | Dentavit, Monarch, Acrotone, Senator, Dentorium | 2013 | 0 |
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, K030588 (Merz Dental GmbH, 2003) has gone furthest, with 7 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?
Acry Pan, Vipi Dent Plus, Biolux, Biolux V, New Dent, Dentoluxx, Vipi Dent N.H. and Vipi Dent V Preformed Plastic Denture Teeth are prefabricated devices, composed of methyl methacrylate material, which are intended for use as teeth in a denture.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K022300 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022300: Acry Pan, Vipi Dent Plus, Biolux, Biolux V, New Dent, Dentoluxx, Vipi Dent N.H., Vipi Dent V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022300
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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