510(k) · Cleared
ClearedDENTCA DENTURE Teeth
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentca, Inc. · PZY Additively Manufactured, Preformed, Resin Denture Tooth
Cleared on Nov 22, 2017 after a 106-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it.
- Decided
- Nov 22, 2017
- Review
- 106 days
- Class
- Class II
- Product code
- PZY
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK172398 DENTCA DENTURE TeethDentca, Inc. · 2017
- Descendant · cites it directly · 6 of its ownK213343 Saremco Print CROWNTECSaremco Dental AG · 2022
- Descendant · 2 generations on · 3 of its ownK233596 VarseoSmile TriniQBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG · 2023
- Descendant · 3 generations on · 1 of its ownK253053 Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)Hangzhou SHINING3D Dental Technology Co., Ltd. · 2025
- Descendant · 4 generations on · 0 of its ownK261356 Dura-CrownHangzhou SHINING3D Dental Technology Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK250497 Additive Manufacturing (Light Curing) Crown Bridge ResinAidite (Qinhuangdao) Technology Co., Ltd. · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K213343Saremco Print CROWNTECSaremco Dental AG · 2022 · cites it directly6descendants
- K233596VarseoSmile TriniQBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG · 2023 · 2 generations on3descendants
- K253053Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)Hangzhou SHINING3D Dental Technology Co., Ltd. · 2025 · 3 generations on1descendant
- K261356Dura-CrownHangzhou SHINING3D Dental Technology Co., Ltd. · 2026 · 4 generations on0descendants
- K250497Additive Manufacturing (Light Curing) Crown Bridge ResinAidite (Qinhuangdao) Technology Co., Ltd. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K172398 | DENTCA DENTURE Teeth | Dentca, Inc. | 2017 | — |
| +1 | K213343 | Saremco Print CROWNTEC | Saremco Dental AG | 2022 | — |
| +2 | K233596 | VarseoSmile TriniQ | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | 2023 | — |
| +3 | K253053 | Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2025 | — |
| +4 | K261356 | Dura-Crown | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026 | — |
| +3 | K250497 | Additive Manufacturing (Light Curing) Crown Bridge Resin | Aidite (Qinhuangdao) Technology Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PZY? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (8)
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?
- Of its descendants, K213343 (Saremco Dental AG, 2022) has gone furthest, with 6 descendants of its own.
How does its category compare?
All PZY devicesPZY Additively Manufactured, Preformed, Resin Denture Tooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PZY
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · PZY
Too few PZY 510(k)s in any year since 2007 to give a median.
Recalls per year · PZY
No recall names PZY since 2007.
Adverse event reports per year · PZY
No MAUDE report names PZY since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
DENTCA Denture Teeth is a light-curable polymerizable resin to fabricate, by additive manufacturing, preformed denture teeth to be used in a denture.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K172398 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172398: DENTCA 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/K172398
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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