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 · NHA Abutment, Implant, Dental, Endosseous
Cleared on Feb 22, 2006 as substantially equivalent to K041283 (Nobel Biocare AB, 2004) after a 107-day review. Its family tree reaches back 3 generations to 1991. 1 later device descends from it.
- Decided
- Feb 22, 2006
- Review
- 107 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K910611 (1991). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK910611 Nobelpharma Ceraone Abutment SystemNobelpharma USA, Inc. · 1991
- 2 generations backK032562 Proceara Copings and PonticNobel Biocare AB · 2004
- 1 generation backK041283 Procera Bridge ZirconiaNobel Biocare AB · 2004
- This deviceK053125 Procera Bridge ZirconiaNobel Biocare AB · 2006
- Descendant · cites it directly · 0 of its ownK071182 Procera Bridge Zirconia 9 Units-14 Units, Models 30-4004 to 30-4013Nobel Biocare AB · 2007
Most influential descendants
Showing 1 of 1 · See all- K071182Procera Bridge Zirconia 9 Units-14 Units, Models 30-4004 to 30-4013Nobel Biocare AB · 2007 · cites it directly0descendants
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 | K041283 | Procera Bridge Zirconia | Nobel Biocare AB | 2004 | — |
| 0 (this device) | K053125 | Procera Bridge Zirconia | Nobel Biocare AB | 2006 | — |
| +1 | 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 |
|---|---|---|
| 2007 | 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 NHA? 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 NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K041283 | Procera Bridge ZirconiaSummary page 1…CFR 872.3920) Trade or Proprietary or Model Name: Procera '~ Bridge Zirconia Legally Marketed Device(s): Procera® Bridge Zirconia (K041283) Device Description: Nobel Biocare's Procera ' Bridge Zirconia is a prefabricated device intended for use as the core structu… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071182 | Procera Bridge Zirconia 9 Units-14 Units, Models 30-4004 to 30-4013 | 2007 | 0 |
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 15 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K071182 (Nobel Biocare AB, 2007) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K041283.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, 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 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
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 consist of two to eights units and is cemented to natural or artificial tooth abutments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053125 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053125: Procera Bridge Zirconia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053125
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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