510(k) · Cleared
ClearedValplast Yamahachi Teeth
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Valplast Intl. Corp. · ELM Denture, Plastic, Teeth
Cleared on Apr 7, 2006 as substantially equivalent to K033628 (Heraeus Kulzer, Inc., 2004) and 1 other predicate after a 39-day review. Its family tree reaches back 2 generations to 2002. 3 later devices descend from it.
- Decided
- Apr 7, 2006
- Review
- 39 days
- Class
- Class II
- Product code
- ELM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K022300 (2002). 5 ancestors in all, the oldest K000213 (2000). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK022300 Acry Pan, Vipi Dent Plus, Biolux, Biolux V, New Dent, Dentoluxx…Dental Vipi Ltda · 2002
- 1 generation backK030588 Artegral and Polystar SelectionMerz Dental GmbH · 2003
- This deviceK060507 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 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 · 2 generations on1descendant
- 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 |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | 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 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
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 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? (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 |
|---|---|---|---|
| * | K033628 | ARTICSummary page 1…ssification Name: Plastic preformed teeth for dentures 3. PREDICATE DEVICES Heraeus Kulzer, inc., Artic Plastic Teeth Dentures subject of K033628 Merz Dental GmbH Artegral and Polystar Selection Preformed Plastic Teeth subject of K030588 4. D… | 2004 |
| * | K030588 | Artegral and Polystar SelectionSummary page 1…Kulzer, inc., Artic Plastic Teeth Dentures subject of K033628 Merz Dental GmbH Artegral and Polystar Selection Preformed Plastic Teeth subject of K030588 4. DEVICE DESCRIPTION The Yamahachi Teeth are anterior and posterior teeth that are intended to be used in… | 2003 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070591 | Replica, Ortolux Top, Odipal, Odilux, Odident, Vitacrilic, Nature's Best, Dental Acrylic… | 2007 | 2 |
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 4 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K070591 (Union Dental S.A./Unidesa.Odi, 2007) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K033628.
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?
The Valplast International Corporation Yamahachi Teeth are prefabricated, preformed plastic teeth that are intended for use as teeth in removable dentures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060507 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060507: Valplast Yamahachi Teeth.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060507
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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