510(k) · Cleared
ClearedProcera Bridge Zirconia
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 May 28, 2004 as substantially equivalent to K032562 (Nobel Biocare AB, 2004) after a 15-day review. Its family tree reaches back 2 generations to 1991. 5 later devices descend from it.
- Decided
- May 28, 2004
- Review
- 15 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. 5 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 deviceK041283 Procera Bridge ZirconiaNobel Biocare AB · 2004
- Descendant · cites it directly · 1 of its ownK053050 Procera Bridge AluminaNobel Biocare AB · 2006
- Descendant · cites it directly · 1 of its ownK053125 Procera Bridge ZirconiaNobel Biocare AB · 2006
- Descendant · 2 generations on · 0 of its ownK130184 ZenoluxWieland Dental + Technik GmbH & Co. KG · 2013
- Descendant · cites it directly · 0 of its ownK091362 Ceramic Pedatric Preformed CrownEz-Pedo, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK071182 Procera Bridge Zirconia 9 Units-14 Units, Models 30-4004 to 30-4013Nobel Biocare AB · 2007
Most influential descendants
Showing 5 of 5 · See all- K053050Procera Bridge AluminaNobel Biocare AB · 2006 · cites it directly1descendant
- K053125Procera Bridge ZirconiaNobel Biocare AB · 2006 · cites it directly1descendant
- K130184ZenoluxWieland Dental + Technik GmbH & Co. KG · 2013 · 2 generations on0descendants
- K091362Ceramic Pedatric Preformed CrownEz-Pedo, Inc. · 2009 · cites it directly0descendants
- K071182Procera Bridge Zirconia 9 Units-14 Units, Models 30-4004 to 30-4013Nobel Biocare AB · 2007 · 2 generations on0descendants
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) | K041283 | Procera Bridge Zirconia | Nobel Biocare AB | 2004 | — |
| +1 | K053050 | Procera Bridge Alumina | Nobel Biocare AB | 2006 | — |
| +1 | K053125 | Procera Bridge Zirconia | Nobel Biocare AB | 2006 | — |
| +2 | K130184 | Zenolux | Wieland Dental + Technik GmbH & Co. KG | 2013 | — |
| +1 | K091362 | Ceramic Pedatric Preformed Crown | Ez-Pedo, Inc. | 2009 | — |
| +2 | K071182 | Procera Bridge Zirconia 9 Units-14 Units, Models 30-4004 to 30-4013 | Nobel Biocare AB | 2007 | — |
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 |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 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 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 1…FR 872.3920) Trade or Proprietary or Model Name: Procera® Bridge Zirconia Legally Marketed Device(s): Procera® Copings & Pontic (K032562) Device Description: Nobel Biocare's Procera® Bridge Zirconia is a prefabricated device intended for use as the core structur… | 2004 |
What descends from it? (5)
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 13 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, K053050 (Nobel Biocare AB, 2006) has gone furthest, with 1 descendant 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.
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?
Nobel Biocare's Procera® Bridge Zirconia is indicated for use as the core structure of an artificial prosthesis for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function. The Procera® Bridge Zirconia may be two, three, or four units and are cemented to natural or artificial tooth abutments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041283 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041283: Procera Bridge Zirconia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041283
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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