510(k) · Cleared
ClearedNobelProcera HT ML Full Contour Zirconia Crown
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobel Biocare AB · ELL Teeth, Porcelain
Cleared on Jun 6, 2016 as substantially equivalent to K032562 (Nobel Biocare AB, 2004) after a 180-day review. Its family tree reaches back 2 generations to 1991. 3 later devices descend from it.
- Decided
- Jun 6, 2016
- Review
- 180 days
- Class
- Class II
- Product code
- ELL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K910611 (1991). 4 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK910611 Nobelpharma Ceraone Abutment SystemNobelpharma USA, Inc. · 1991
- 1 generation backK032562 Proceara Copings and PonticNobel Biocare AB · 2004
- This deviceK153534 NobelProcera HT ML Full Contour Zirconia CrownNobel Biocare AB · 2016
- Descendant · cites it directly · 0 of its ownK240586 Additive Manufacturing Zirconia Customized RestorationHangzhou Thales Medtech Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK203072 Franz Zirconia Dental CrownFranz Biotech, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK162043 NobelProcera HT ML FCZ BridgeNobel Biocare AB · 2016
Most influential descendants
Showing 3 of 3 · See all- K240586Additive Manufacturing Zirconia Customized RestorationHangzhou Thales Medtech Co., Ltd. · 2024 · cites it directly0descendants
- K203072Franz Zirconia Dental CrownFranz Biotech, Inc. · 2022 · cites it directly0descendants
- K162043NobelProcera HT ML FCZ BridgeNobel Biocare AB · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K910611 | Nobelpharma Ceraone Abutment System | Nobelpharma USA, Inc. | 1991 | — |
| −1 | K032562 | Proceara Copings and Pontic | Nobel Biocare AB | 2004 | — |
| 0 (this device) | K153534 | NobelProcera HT ML Full Contour Zirconia Crown | Nobel Biocare AB | 2016 | — |
| +1 | K240586 | Additive Manufacturing Zirconia Customized Restoration | Hangzhou Thales Medtech Co., Ltd. | 2024 | — |
| +1 | K203072 | Franz Zirconia Dental Crown | Franz Biotech, Inc. | 2022 | — |
| +1 | K162043 | NobelProcera HT ML FCZ Bridge | Nobel Biocare AB | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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 ELL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ELL device
- #1 K240586 Additive Manufacturing Zirconia Customized…score 8.7 · 3 generations · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K032562 | Proceara Copings and PonticSummary page 4…h (21 CFR 872.3920) Regulatory Class: II Product Code: ELL III.PREDICATE DEVICE Primary predicate: Nobel Biocare – Procera Copings and Pontic (K032562) Reference predicate: Kuraray Noritake Dental Inc. – Katana Zirconia (K143439) IV. DEVICE DESCRIPTION Nobe… | 2004 |
| † | K143439 | KATANA Zirconia | 2015 |
What descends from it? (3)
3 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?
- The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 12.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K240586 (Hangzhou Thales Medtech Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K032562.
How does its category compare?
All ELL devicesELL Teeth, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · ELL
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · ELL
Too few ELL 510(k)s in any year since 2007 to give a median.
Recalls per year · ELL
No recall names ELL since 2007.
Adverse event reports per year · ELL
1in 2020
MAUDE reports naming product code ELL, 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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
NobelProcera HT ML FCZ Crown is indicated for use as core structure of an artificial prosthesis for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function.
NobelProcera HT ML FCZ Crown is indicated for use as single crown that will be cemented to a natural or artificial tooth abutment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153534 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153534: NobelProcera HT ML Full Contour Zirconia Crown.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153534
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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