510(k) · Cleared
ClearedProcera Bridge Zirconia 9 Units-14 Units, Models 30-4004 to 30-4013
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 Jul 11, 2007 as substantially equivalent to K053125 (Nobel Biocare AB, 2006) after a 72-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Jul 11, 2007
- Review
- 72 days
- Class
- Class II
- Product code
- ELL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K910611 (1991). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK910611 Nobelpharma Ceraone Abutment SystemNobelpharma USA, Inc. · 1991
- 3 generations backK032562 Proceara Copings and PonticNobel Biocare AB · 2004
- 2 generations backK041283 Procera Bridge ZirconiaNobel Biocare AB · 2004
- 1 generation backK053125 Procera Bridge ZirconiaNobel Biocare AB · 2006
- This deviceK071182 Procera Bridge Zirconia 9 Units-14 Units, Models 30-4004 to 30-4013Nobel Biocare AB · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K910611 | Nobelpharma Ceraone Abutment System | Nobelpharma USA, Inc. | 1991 | — |
| −3 | K032562 | Proceara Copings and Pontic | Nobel Biocare AB | 2004 | — |
| −2 | K041283 | Procera Bridge Zirconia | Nobel Biocare AB | 2004 | — |
| −1 | K053125 | Procera Bridge Zirconia | Nobel Biocare AB | 2006 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K053125 | Procera Bridge ZirconiaSummary page 1…1 CFR 872.3920) Trade or Proprietary or Model Name: Procera Bridge Zirconia Legally Marketed Device(s): Procera Bridge Zirconia (K053125) Device Description: Nobel Biocare's Procera Bridge Zirconia is a prefabricated device intended for use as the core structure… | 2006 |
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 16 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All ELL devicesELL Teeth, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
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 cemented or bonded to either natural or artificial tooth abutments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071182 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071182: Procera Bridge Zirconia 9 Units-14 Units, Models 30-4004 to 30-4013.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071182
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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