510(k) · Cleared
ClearedMerz Dental GMBH Artegral HD Preformed Plastic Denture Teeth
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merz Dental GmbH · ELM Denture, Plastic, Teeth
Cleared on May 21, 2012 as substantially equivalent to K030588 (Merz Dental GmbH, 2003) after a 102-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- May 21, 2012
- Review
- 102 days
- Class
- Class II
- Product code
- ELM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K022300 (2002). No later device cites it as a predicate yet.
- 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 deviceK120404 Merz Dental GMBH Artegral HD Preformed Plastic Denture TeethMerz Dental GmbH · 2012
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) | K120404 | Merz Dental GMBH Artegral HD Preformed Plastic Denture Teeth | Merz Dental GmbH | 2012 | — |
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? (1)
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 |
|---|---|---|---|
| * | K030588 | Artegral and Polystar SelectionSummary page 1…ietary name: artegral RD Common name: Denture teeth Classification name: Denture, plastic, teeth (2ICFR 872.3590 Product Code ELM) Predicate Device K030588, Merz Dental GmbH artegral and Polystar Selection Denture Plastic Teeth Device Description artegral ND are preformed posterior… | 2003 |
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 10 years and passes through 2 companies; a new generation was cleared every 9.0 years on median.
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K030588.
How does its category compare?
All ELM devicesELM Denture, Plastic, Teeth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Artegral HO are posterior preformed plastic denture teeth for use in:
* supra construction for combined, fixed removable dental prostheses
* hybrid construction for implant-supported dental prostheses
* cover denture
* total prostheses
* model cast prostheses
* partial dentures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120404 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120404: Merz Dental GMBH Artegral HD Preformed Plastic Denture Teeth.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120404
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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