510(k) · Cleared
ClearedDentavit, Monarch, Acrotone, Senator, Dentorium
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wright Health Group, Ltd. · ELM Denture, Plastic, Teeth
Cleared on Mar 1, 2013 as substantially equivalent to K070591 (Union Dental S.A./Unidesa.Odi, 2007) and 3 other predicates after a 157-day review. Its family tree reaches back 5 generations to 2002.
- Decided
- Mar 1, 2013
- Review
- 157 days
- Class
- Class II
- Product code
- ELM
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K022300 (2002). 13 ancestors in all, the oldest K792245 (1980). No later device cites it as a predicate yet.
- Root · 5 generations backK022300 Acry Pan, Vipi Dent Plus, Biolux, Biolux V, New Dent, Dentoluxx…Dental Vipi Ltda · 2002
- 4 generations backK030588 Artegral and Polystar SelectionMerz Dental GmbH · 2003
- 3 generations backK060507 Valplast Yamahachi TeethValplast Intl. Corp. · 2006
- 2 generations backK070591 Replica, Ortolux Top, Odipal, Odilux, Odident, Vitacrilic, Nature's…Union Dental S.A./Unidesa.Odi · 2007
- 1 generation backK101029 Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, Maist and Kaitong/Royal…Huge Dental Material Co., Ltd. · 2010
- This deviceK122955 Dentavit, Monarch, Acrotone, Senator, DentoriumWright Health Group, Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K022300 | Acry Pan, Vipi Dent Plus, Biolux, Biolux V, New Dent, Dentoluxx, Vipi Dent… | Dental Vipi Ltda | 2002 | — |
| −4 | K030588 | Artegral and Polystar Selection | Merz Dental GmbH | 2003 | — |
| −3 | K060507 | Valplast Yamahachi Teeth | Valplast Intl. Corp. | 2006 | — |
| −2 | 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 | — |
| 0 (this device) | K122955 | Dentavit, Monarch, Acrotone, Senator, Dentorium | Wright Health Group, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1992 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 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 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? (4)
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 |
|---|---|---|---|
| * | K070591 | Replica, Ortolux Top, Odipal, Odilux, Odident, Vitacrilic, Nature's Best, Dental Acrylic…Summary page 1…els: Dentavit, Monarch, Acrotone, Senator, Dentorium Classification: 11 Product Code: ELM Regulation: 21 CFR 872.3590 PREDICATE DEVICES: Union Dental S.A./ Unidesa Odi K070591 - model Replica Dental Vipi Ltd K022300 - model Vipi Dent Plus Vident K(914476 - model Vitapan Huge Dental Material Co., Ltd. K 1… | 2007 |
| * | K022300 | Acry Pan, Vipi Dent Plus, Biolux, Biolux V, New Dent, Dentoluxx, Vipi Dent N.H., Vipi…Summary page 1…r, Dentorium Classification: 11 Product Code: ELM Regulation: 21 CFR 872.3590 PREDICATE DEVICES: Union Dental S.A./ Unidesa Odi K070591 - model Replica Dental Vipi Ltd K022300 - model Vipi Dent Plus Vident K(914476 - model Vitapan Huge Dental Material Co., Ltd. K 10 1029 - model Kaili DESCRIPTION:… | 2002 |
| * | K914476 | Vitapan Acrylic Denture TeethSummary page 1…Code: ELM Regulation: 21 CFR 872.3590 PREDICATE DEVICES: Union Dental S.A./ Unidesa Odi K070591 - model Replica Dental Vipi Ltd K022300 - model Vipi Dent Plus Vident K(914476 - model Vitapan Huge Dental Material Co., Ltd. K 10 1029 - model Kaili DESCRIPTION:… | 1992 |
| * | K101029 | Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, Maist and Kaitong/Royal Synthetic Polymer TeethSummary page 1…ES: Union Dental S.A./ Unidesa Odi K070591 - model Replica Dental Vipi Ltd K022300 - model Vipi Dent Plus Vident K(914476 - model Vitapan Huge Dental Material Co., Ltd. K 10 1029 - model Kaili DESCRIPTION: a Thesynt… | 2010 |
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?
- The line of descent spans 11 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- None of the 13 ancestors has a recall.
- 1 other device also cites its predicate K070591.
How does its category compare?
All ELM devicesELM Denture, Plastic, Teeth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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?
These dental plastic teeth are parts used for denture fabrication. PMMA is mixed with monomer in a polymerization process. The plastic teeth are part of dentures made to fit a patient's mouth which are removable or may be attached to dental implant devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122955 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122955: Dentavit, Monarch, Acrotone, Senator, Dentorium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122955
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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