510(k) · Cleared
ClearedNobelProcera HT ML FCZ Bridge
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 Nov 22, 2016 as substantially equivalent to K153534 (Nobel Biocare AB, 2016) after a 120-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Nov 22, 2016
- Review
- 120 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 deviceK162043 NobelProcera HT ML FCZ BridgeNobel Biocare AB · 2016
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) | 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 |
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 |
|---|---|---|---|
| * | K153534 | NobelProcera HT ML Full Contour Zirconia CrownSummary page 4…tooth (21 CFR 872.3920) Regulatory Class: II Product Code: ELL III. PREDICATE DEVICE Primary predicate: Nobel Biocare – NobelProcera HT ML Full Contour Zirconia Crown (K153534) Reference predicates: Nobel Biocare – Procera Bridge Zirconia (K071182) Kuraray Noritake Dental Inc. – Katana Zirconia (K143439… | 2016 |
| † | K071182 | Procera Bridge Zirconia 9 Units-14 Units, Models 30-4004 to 30-4013 | 2007 |
| † | K143439 | KATANA Zirconia | 2015 |
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 25 years and passes through 2 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. 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 Bridge 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 Bridge is indicated for use as a bridge that will be cemented on natural teeth or artificial abutments.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162043 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162043: NobelProcera HT ML FCZ Bridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162043
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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