510(k) · Cleared
ClearedARTIC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heraeus Kulzer, Inc. · ELM Denture, Plastic, Teeth
Cleared on Jan 16, 2004 as substantially equivalent to K000213 (J.F. Jelenko & Co., 2000) and 1 other predicate after a 58-day review. Its family tree reaches back 1 generation to 2000. 4 later devices descend from it.
- Decided
- Jan 16, 2004
- Review
- 58 days
- Class
- Class II
- Product code
- ELM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K000213 (2000). 2 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK000213 Jeldent Basic LineJ.F. Jelenko & Co. · 2000
- This deviceK033628 ARTICHeraeus Kulzer, Inc. · 2004
- Descendant · cites it directly · 3 of its ownK060507 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 4 of 4 · See all- K060507Valplast Yamahachi TeethValplast Intl. Corp. · 2006 · cites it directly3descendants
- 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 |
|---|---|---|---|---|---|
| −1 | K000213 | Jeldent Basic Line | J.F. Jelenko & Co. | 2000 | — |
| 0 (this device) | K033628 | ARTIC | Heraeus Kulzer, Inc. | 2004 | — |
| +1 | 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 |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K000213 | Jeldent Basic LineSummary page 1…Preformed Plastic Denture Tooth Proprietary Name: Artic® Common Name: Denture Tooth Equivalent Device JelDent Basic [K000213] Premium [K011130] Description for the Premarket Notification Artic is classified as Preformed Plastic Te… | 2000 |
| * | K011130 | PremiumSummary page 1…th Proprietary Name: Artic® Common Name: Denture Tooth Equivalent Device JelDent Basic [K000213] Premium [K011130] Description for the Premarket Notification Artic is classified as Preformed Plastic Teeth (21C.F.R. § 872.3590) Under… | 2001 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K060507 (Valplast Intl. Corp., 2006) has gone furthest, with 3 descendants of its own.
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?
Artic line are artificial synthethic resin permanent teeth. The enamel and dentine
layers of HK teerh are highly cross-linked and suit the rate of natural abrasion.
The base of the tooth is less cross-linked to achieve optimum bonding between
the tooth and the denture acrylic
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033628 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033628: ARTIC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033628
Report an extraction error
Are you the manufacturer?
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