510(k) Report

510(k) · Cleared

Cleared

Replica, Ortolux Top, Odipal, Odilux, Odident, Vitacrilic, Nature's Best, Dental Acrylic Teeth

K070591510(k) TraditionalCleared May 11, 200771-day reviewClass II21 CFR 872.3590

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Union Dental S.A./Unidesa.Odi · ELM Denture, Plastic, Teeth

Cleared on May 11, 2007 as substantially equivalent to K033628 (Heraeus Kulzer, Inc., 2004) and 7 other predicates after a 71-day review. Its family tree reaches back 3 generations to 2002. 2 later devices descend from it.

Decided
May 11, 2007
Review
71 days
Class
Class II
Product code
ELM
Recalls
None
Predicates
8

Its longest line of descent runs back 3 generations to K022300 (2002). 10 ancestors in all, the oldest K792245 (1980). 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2004: 1 other ancestor2002: 1 other ancestor1992: 1 other ancestor1980: 1 other ancestor2001: 1 other ancestor2000: 1 other ancestor2010: 1 descendant cleared2013: 1 descendant clearedK022300 · Acry Pan, Vipi Dent Plus, Biolux, Biolux V, New Dent, Dentoluxx, Vipi Dent N.H., Vipi Dent V · Dental Vipi Ltda · 2002K030588 · Artegral and Polystar Selection · Merz Dental GmbH · 2003K060507 · Valplast Yamahachi Teeth · Valplast Intl. Corp. · 200619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 2 other ancestors 1 generation forward: 2 descendants K060507 · Valplast Yamahachi Teeth · Valplast Intl. Corp. · 2006K030588 · Artegral and Polystar Selection · Merz Dental GmbH · 2003K022300 · Acry Pan, Vipi Dent Plus, Biolux, Biolux V, New Dent, Dentoluxx, Vipi Dent N.H., Vipi Dent V · Dental Vipi Ltda · 20020
  1. Root · 3 generations backK022300 Acry Pan, Vipi Dent Plus, Biolux, Biolux V, New Dent, Dentoluxx…Dental Vipi Ltda · 2002
  2. 2 generations backK030588 Artegral and Polystar SelectionMerz Dental GmbH · 2003
  3. 1 generation backK060507 Valplast Yamahachi TeethValplast Intl. Corp. · 2006
  4. This deviceK070591 Replica, Ortolux Top, Odipal, Odilux, Odident, Vitacrilic, Nature's…Union Dental S.A./Unidesa.Odi · 2007
  5. Descendant · cites it directly · 1 of its ownK101029 Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, Maist and Kaitong/Royal…Huge Dental Material Co., Ltd. · 2010
  6. Descendant · cites it directly · 0 of its ownK122955 Dentavit, Monarch, Acrotone, Senator, DentoriumWright Health Group, Ltd. · 2013

Most influential descendants

Showing 2 of 2 · See all
  • 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 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K022300Acry Pan, Vipi Dent Plus, Biolux, Biolux V, New Dent, Dentoluxx, Vipi Dent…Dental Vipi Ltda2002—
−2K030588Artegral and Polystar SelectionMerz Dental GmbH2003—
−1K060507Valplast Yamahachi TeethValplast Intl. Corp.2006—
0 (this device)K070591Replica, Ortolux Top, Odipal, Odilux, Odident, Vitacrilic, Nature's Best…Union Dental S.A./Unidesa.Odi2007—
+1K101029Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, Maist and Kaitong/Royal Synthetic…Huge Dental Material Co., Ltd.2010—
+1K122955Dentavit, Monarch, Acrotone, Senator, DentoriumWright Health Group, Ltd.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
199210
200010
200110
200210
200410
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201310
FIG. 1 — Lineage of K070591, 2002–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
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What was it cleared against? (8)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K033628ARTIC
Summary page 1
…. teeth (510K-K792245) Nobelpharma Usa,Inc. teeth (510K-K915276) Yamhachi. teeth (510K-K060507) Artegral and polystar Selection teeth (510K-K{130588) Artic teeth (ST0K-K033628) Trilux. Z-tone, Acryrock teeth (510K-K022299) Acry Pan, Vipi Dent Plus, teeth (510K-K022300) Wicdent Estetic teeth (510K-K0613…
Heraeus Kulzer, Inc.2004—
*K792245Teeth, Denture, Plastic
Summary page 1
…al. Odilux, Odident, Vitacrilic, Natures Best Common name: Denture teeth Predicate Devices IHeraeus Kulzer Artic plastic teeth (510K-K033:28) Dentsply Int. teeth (510K-K792245) Nobelpharma Usa,Inc. teeth (510K-K915276) Yamhachi. teeth (510K-K060507) Artegral and polystar Selection teeth (510K-K{130588)…
Dentsply Intl.1980—
*K915276Denture Plastic Teeth,76 Elm
Summary page 1
…st Common name: Denture teeth Predicate Devices IHeraeus Kulzer Artic plastic teeth (510K-K033:28) Dentsply Int. teeth (510K-K792245) Nobelpharma Usa,Inc. teeth (510K-K915276) Yamhachi. teeth (510K-K060507) Artegral and polystar Selection teeth (510K-K{130588) Artic teeth (ST0K-K033628) Trilux. Z-tone…
Nobelpharma USA, Inc.1992—
*K060507Valplast Yamahachi Teeth
Summary page 1
…Predicate Devices IHeraeus Kulzer Artic plastic teeth (510K-K033:28) Dentsply Int. teeth (510K-K792245) Nobelpharma Usa,Inc. teeth (510K-K915276) Yamhachi. teeth (510K-K060507) Artegral and polystar Selection teeth (510K-K{130588) Artic teeth (ST0K-K033628) Trilux. Z-tone, Acryrock teeth (510K-K022299)…
Valplast Intl. Corp.2006—
*K030588Artegral and Polystar Selection
Our OCR of the scanned summary read K130588, FDA’s number for Merit Hydrophilic Guide Wire (Merit Medical Systems, Inc.), decided Apr 5, 2013, after this device. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Artegral and Polystar Selection teeth”.
Merz Dental GmbH2003—
*K022299Trilux, Z-Tone, Acry Rock
Summary page 1
…eth (510K-K915276) Yamhachi. teeth (510K-K060507) Artegral and polystar Selection teeth (510K-K{130588) Artic teeth (ST0K-K033628) Trilux. Z-tone, Acryrock teeth (510K-K022299) Acry Pan, Vipi Dent Plus, teeth (510K-K022300) Wicdent Estetic teeth (510K-K061337) The device is similar in size, shape. colo…
Ruthibras Imp. Exp. Com. DE Materiais Odontologico2002—
*K022300Acry Pan, Vipi Dent Plus, Biolux, Biolux V, New Dent, Dentoluxx, Vipi Dent N.H., Vipi…
Summary page 1
…) Artegral and polystar Selection teeth (510K-K{130588) Artic teeth (ST0K-K033628) Trilux. Z-tone, Acryrock teeth (510K-K022299) Acry Pan, Vipi Dent Plus, teeth (510K-K022300) Wicdent Estetic teeth (510K-K061337) The device is similar in size, shape. color, chemical composition and usage as the above p…
Dental Vipi Ltda2002—
*K061337Wiedent Estetic
Summary page 1
…eth (510K-K{130588) Artic teeth (ST0K-K033628) Trilux. Z-tone, Acryrock teeth (510K-K022299) Acry Pan, Vipi Dent Plus, teeth (510K-K022300) Wicdent Estetic teeth (510K-K061337) The device is similar in size, shape. color, chemical composition and usage as the above products. CETAAN Nuvmhar KNT089] Page…
Xpdent Corp2006—

Also cleared against K033628: 1 other device →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K101029Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, Maist and Kaitong/Royal Synthetic Polymer TeethHuge Dental Material Co., Ltd.20101
K122955Dentavit, Monarch, Acrotone, Senator, DentoriumWright Health Group, Ltd.20130

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 5 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
  • None of the 10 ancestors has a recall.
  • Of its descendants, K101029 (Huge Dental Material Co., Ltd., 2010) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K033628.

How does its category compare?

All ELM devices

ELM Denture, Plastic, Teeth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · ELM

1in 2014

2007: 12009: 12010: 32012: 52013: 22014: 1
2007high 5 (2012) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ELM

82in 2012

2010: 125 days median2012: 82 days median
2007high 125 (2010) · low 82 (2012)2026

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

2008: 12012: 42013: 432017: 12018: 12020: 12025: 1
2007high 43 (2013) · low 0 (2007)2025

MAUDE reports naming product code ELM, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—01
20091—00
2010312500
20110—00
201258204
20132—043
20141—00
20150—00
20160—00
20170—01
20180—01
20190—00
20200—01
20210—00
20220—00
20230—00
20240—00
20250—01
20260—0—

What is it indicated for?

Teeth for the fabrication of dentures

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 patients mouth and is a removable. It is not implanted.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K033628

1 other device cites the same predicate.

  • K060507Valplast Yamahachi TeethValplast Intl. Corp. · 2006

Recent decisions in ELM

The ELM category page

  • K132984SR Vivodent S, SR Orthotyp S, SR Ortholingual SIvoclar Vivadent, Inc. · 2014
  • K122955Dentavit, Monarch, Acrotone, Senator, DentoriumWright Health Group, Ltd. · 2013
  • K122925New Stetic Artificial TeethNew Stetic · 2013
  • K122852Physiostar NFCCandulor USA, Inc. · 2012
  • K121749VeraciaShofu Dental Corporation · 2012

https://510kreport.com/device/K070591 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070591: Replica, Ortolux Top, Odipal, Odilux, Odident, Vitacrilic, Nature's Best, Dental Acrylic Teeth.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070591

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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