510(k) · Cleared
ClearedProcera Implant 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 Jan 27, 2006 as substantially equivalent to K043042 (Nobel Biocare AB, 2004) and 1 other predicate after an 85-day review. Its family tree reaches back 7 generations to 1995. 6 later devices descend from it.
- Decided
- Jan 27, 2006
- Review
- 85 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K944964 (1995). 60 ancestors in all, the oldest K871863 (1987). 6 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 6 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 5 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 4 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 3 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 2 generations backK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
- 1 generation backK043042 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004
- This deviceK053091 Procera Implant Bridge ZirconiaNobel Biocare AB · 2006
- Descendant · cites it directly · 5 of its ownK091907 Nobelprocera Implant Bridge ZirconiaNobel Biocare AB · 2009
- Descendant · 2 generations on · 3 of its ownK160158 NobelProcera HT ML FCZ Implant Bridge and FrameworkNobel Biocare AB · 2016
- Descendant · 3 generations on · 2 of its ownK202452 NobelProcera Zirconia Implant BridgeNobel Biocare AB · 2020
- Descendant · 4 generations on · 0 of its ownK253999 Universal Base ASC Engaging; Universal Base ASC Non-Engaging…Nobel Biocare AB · 2026
- Descendant · 4 generations on · 0 of its ownK240346 NobelProcera Zirconia Implant BridgeNobel Biocare AB · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K091907Nobelprocera Implant Bridge ZirconiaNobel Biocare AB · 2009 · cites it directly5descendants
- K160158NobelProcera HT ML FCZ Implant Bridge and FrameworkNobel Biocare AB · 2016 · 2 generations on3descendants
- K202452NobelProcera Zirconia Implant BridgeNobel Biocare AB · 2020 · 3 generations on2descendants
- K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…Nobel Biocare AB · 2026 · 4 generations on0descendants
- K240346NobelProcera Zirconia Implant BridgeNobel Biocare AB · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −6 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −5 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −4 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −3 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −2 | K032263 | 3I Patient-Specific Dental Abutment and Overdenture Bar | Implant Innovations, Inc. | 2004 | 1 |
| −1 | K043042 | Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 | Nobel Biocare AB | 2004 | — |
| 0 (this device) | K053091 | Procera Implant Bridge Zirconia | Nobel Biocare AB | 2006 | — |
| +1 | K091907 | Nobelprocera Implant Bridge Zirconia | Nobel Biocare AB | 2009 | — |
| +2 | K160158 | NobelProcera HT ML FCZ Implant Bridge and Framework | Nobel Biocare AB | 2016 | — |
| +3 | K202452 | NobelProcera Zirconia Implant Bridge | Nobel Biocare AB | 2020 | — |
| +4 | K253999 | Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base… | Nobel Biocare AB | 2026 | — |
| +4 | K240346 | NobelProcera Zirconia Implant Bridge | Nobel Biocare AB | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 9 | 0 |
| 1994 | 9 | 0 |
| 1995 | 6 | 0 |
| 1996 | 6 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 30.7 · 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? (2)
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 |
|---|---|---|---|
| * | K043042 | Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Summary page 1…640) Trade or Proprietary or Model Name: Procera® Implant Bridge Zirconia Legally Marketed Device(s): Procera® Implant Bridge (K043042) Procera"~Implant Bridge (K041236) Device ecr~tin Procerar- Implant Bridge Zircon… | 2004 |
| * | K041236 | Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Summary page 1…a® Implant Bridge Zirconia Legally Marketed Device(s): Procera® Implant Bridge (K043042) Procera"~Implant Bridge (K041236) Device ecr~tin Procerar- Implant Bridge Zirconia is a dental prosthetic framework milled from one solid piece of Zirconia… | 2004 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091907 | Nobelprocera Implant Bridge Zirconia | 2009 | 5 |
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 11 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 8 of the 60 ancestors have a recall of any class.
- Of its descendants, K091907 (Nobel Biocare AB, 2009) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K043042.
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?
The Procera Implant Bridge Zirconia is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.
In addition to Nobel Biocare implant systems, the Procera Implant Bridge Zirconia can be used on the following implant systems:
- Straumann Dental Implant System Regular Neck 4.8
- Straumann Dental Implant System Wide Neck 6.5
- 3i 3.75
- Lifecore Biomedical Restore 3.75
- Zimmer Dental Taper-Lock 4.0
- Sterngold Implamed 3.75
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053091 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053091: Procera Implant Bridge Zirconia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053091
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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