510(k) · Cleared
ClearedFranz Zirconia Dental Crown
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Franz Biotech, Inc. · ELL Teeth, Porcelain
Cleared on Jan 19, 2022 as substantially equivalent to K153534 (Nobel Biocare AB, 2016) after a 467-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Jan 19, 2022
- Review
- 467 days
- Class
- Class II
- Product code
- ELL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K910611 (1991). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK910611 Nobelpharma Ceraone Abutment SystemNobelpharma USA, Inc. · 1991
- 2 generations backK032562 Proceara Copings and PonticNobel Biocare AB · 2004
- 1 generation backK153534 NobelProcera HT ML Full Contour Zirconia CrownNobel Biocare AB · 2016
- This deviceK203072 Franz Zirconia Dental CrownFranz Biotech, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K910611 | Nobelpharma Ceraone Abutment System | Nobelpharma USA, Inc. | 1991 | — |
| −2 | K032562 | Proceara Copings and Pontic | Nobel Biocare AB | 2004 | — |
| −1 | K153534 | NobelProcera HT ML Full Contour Zirconia Crown | Nobel Biocare AB | 2016 | — |
| 0 (this device) | K203072 | Franz Zirconia Dental Crown | Franz Biotech, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 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
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 |
|---|---|---|---|
| * | K153534 | NobelProcera HT ML Full Contour Zirconia CrownSummary page 4…CFR Part 872.3920 Device Class II Classification Panel Dental 3 Predicate Device Name 510(k) number: K153534 Trade or proprietary or NobelProcera HT ML Full Contour Zirconia model name: Crown… | 2016 |
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 31 years and passes through 3 companies; a new generation was cleared every 12.3 years on median.
- None of the 5 ancestors has a recall.
- 2 other devices also cite its predicate K153534.
How does its category compare?
All ELL devicesELL Teeth, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Franz Zirconia Dental Crown is indicated for use as main structure of an artificial dental prothesis for partially edentulous patients which require prosthetic oral reconstruction to restore chewing function.
Franz Zirconia Dental Crown is indicated for use as single crown that will be cemented to an artificial or natural tooth abutment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203072 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203072: Franz Zirconia Dental Crown.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203072
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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