510(k) · Cleared
ClearedKaifeng/Crystal, Kaili, Kaijing, Kaiyue, Maist and Kaitong/Royal Synthetic Polymer Teeth
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Huge Dental Material Co., Ltd. · ELM Denture, Plastic, Teeth
Cleared on Aug 16, 2010 as substantially equivalent to K061337 (Xpdent Corp, 2006) and 2 other predicates after a 125-day review. Its family tree reaches back 4 generations to 2002. 1 later device descends from it.
- Decided
- Aug 16, 2010
- Review
- 125 days
- Class
- Class II
- Product code
- ELM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K022300 (2002). 11 ancestors in all, the oldest K792245 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK022300 Acry Pan, Vipi Dent Plus, Biolux, Biolux V, New Dent, Dentoluxx…Dental Vipi Ltda · 2002
- 3 generations backK030588 Artegral and Polystar SelectionMerz Dental GmbH · 2003
- 2 generations backK060507 Valplast Yamahachi TeethValplast Intl. Corp. · 2006
- 1 generation backK070591 Replica, Ortolux Top, Odipal, Odilux, Odident, Vitacrilic, Nature's…Union Dental S.A./Unidesa.Odi · 2007
- This deviceK101029 Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, Maist and Kaitong/Royal…Huge Dental Material Co., Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK122955 Dentavit, Monarch, Acrotone, Senator, DentoriumWright Health Group, Ltd. · 2013
Most influential descendants
Showing 1 of 1 · See all- K122955Dentavit, Monarch, Acrotone, Senator, DentoriumWright Health Group, Ltd. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K022300 | Acry Pan, Vipi Dent Plus, Biolux, Biolux V, New Dent, Dentoluxx, Vipi Dent… | Dental Vipi Ltda | 2002 | — |
| −3 | 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 | — |
| 0 (this device) | K101029 | Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, Maist and Kaitong/Royal Synthetic… | Huge Dental Material Co., Ltd. | 2010 | — |
| +1 | 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 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K061337 | Wiedent EsteticSummary page 1…h Device Class: II Classification Name: Preformed Plastic Denture Tooth Regulation Number: 21 CFR 872.3590 Product Code: ELM Review Panel: Dental Predicate Device: * K061337, XPDENT CORPORATION WJEDENT ESTHETIC TEETH * K070591, UNION DENTAL S.A./UNIDESA.ODI REPLICA, ORTOLUX TOP, ODIP… | 2006 |
| * | K070591 | Replica, Ortolux Top, Odipal, Odilux, Odident, Vitacrilic, Nature's Best, Dental Acrylic…Summary page 1…Tooth Regulation Number: 21 CFR 872.3590 Product Code: ELM Review Panel: Dental Predicate Device: * K061337, XPDENT CORPORATION WJEDENT ESTHETIC TEETH * K070591, UNION DENTAL S.A./UNIDESA.ODI REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACR… | 2007 |
| * | K022300 | Acry Pan, Vipi Dent Plus, Biolux, Biolux V, New Dent, Dentoluxx, Vipi Dent N.H., Vipi…Summary page 1…TEETH * K070591, UNION DENTAL S.A./UNIDESA.ODI REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH * K022300, DENTAL VIPI LTDA ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIP] DENT N.H., VIPI DENT V PERF… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| 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?
- The line of descent spans 8 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K122955 (Wright Health Group, Ltd., 2013) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K061337.
How does its category compare?
All ELM devicesELM Denture, Plastic, Teeth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
It is intended for use as a tooth in a denture.
These teeth are used for making full or partial dentures. The artificial resin teeth are mounted on an appliance made of dental acrylic resin. The appliance is made to fit the patient's mouth and is a removable. It is not implanted.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101029 · printed Nov 5, 2026
Cite this page
510(k) Report. “K101029: Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, Maist and Kaitong/Royal Synthetic Polymer Teeth.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K101029
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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