510(k) · Cleared
ClearedNobelprocera 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 Oct 6, 2009 as substantially equivalent to K090069 (Nobel Biocare AB, 2009) and 1 other predicate after a 103-day review. Its family tree reaches back 8 generations to 1995. 5 later devices descend from it.
- Decided
- Oct 6, 2009
- Review
- 103 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K944964 (1995). 62 ancestors in all, the oldest K871863 (1987). 5 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 7 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 6 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 5 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 4 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 3 generations backK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
- 2 generations backK043042 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004
- 1 generation backK053091 Procera Implant Bridge ZirconiaNobel Biocare AB · 2006
- This deviceK091907 Nobelprocera Implant Bridge ZirconiaNobel Biocare AB · 2009
- Descendant · cites it directly · 3 of its ownK160158 NobelProcera HT ML FCZ Implant Bridge and FrameworkNobel Biocare AB · 2016
- Descendant · 2 generations on · 2 of its ownK202452 NobelProcera Zirconia Implant BridgeNobel Biocare AB · 2020
- Descendant · 3 generations on · 0 of its ownK253999 Universal Base ASC Engaging; Universal Base ASC Non-Engaging…Nobel Biocare AB · 2026
- Descendant · 3 generations on · 0 of its ownK240346 NobelProcera Zirconia Implant BridgeNobel Biocare AB · 2025
- Descendant · cites it directly · 0 of its ownK100356 TDS Precision Dental BarPou YU Biotechnology Co., Ltd. · 2010
Most influential descendants
Showing 5 of 5 · See all- K160158NobelProcera HT ML FCZ Implant Bridge and FrameworkNobel Biocare AB · 2016 · cites it directly3descendants
- K202452NobelProcera Zirconia Implant BridgeNobel Biocare AB · 2020 · 2 generations on2descendants
- K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…Nobel Biocare AB · 2026 · 3 generations on0descendants
- K240346NobelProcera Zirconia Implant BridgeNobel Biocare AB · 2025 · 3 generations on0descendants
- K100356TDS Precision Dental BarPou YU Biotechnology Co., Ltd. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −7 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −6 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −5 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −4 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −3 | K032263 | 3I Patient-Specific Dental Abutment and Overdenture Bar | Implant Innovations, Inc. | 2004 | 1 |
| −2 | K043042 | Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 | Nobel Biocare AB | 2004 | — |
| −1 | K053091 | Procera Implant Bridge Zirconia | Nobel Biocare AB | 2006 | — |
| 0 (this device) | K091907 | Nobelprocera Implant Bridge Zirconia | Nobel Biocare AB | 2009 | — |
| +1 | K160158 | NobelProcera HT ML FCZ Implant Bridge and Framework | Nobel Biocare AB | 2016 | — |
| +2 | K202452 | NobelProcera Zirconia Implant Bridge | Nobel Biocare AB | 2020 | — |
| +3 | K253999 | Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base… | Nobel Biocare AB | 2026 | — |
| +3 | K240346 | NobelProcera Zirconia Implant Bridge | Nobel Biocare AB | 2025 | — |
| +1 | K100356 | TDS Precision Dental Bar | Pou YU Biotechnology Co., Ltd. | 2010 | — |
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 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K090069 | Procera Implant Bridge OverdentureSummary page 1…ade or Proprietary or Model Name: NobelProcera Implant Bridge Zirconia Legally Marketed Devices: Nobel Biocare - Procera Implant Bridge Overdenture (K090069) Nobel Biocare - Procera Implant Bridge Zirconia (K053091) Device Description: Nobel Biocare's NobelPr… | 2009 |
| * | K053091 | Procera Implant Bridge ZirconiaSummary page 1…irconia Legally Marketed Devices: Nobel Biocare - Procera Implant Bridge Overdenture (K090069) Nobel Biocare - Procera Implant Bridge Zirconia (K053091) Device Description: Nobel Biocare's NobelProcera Implant Bridge Zirconia is a bridge framework that attaches to implants or abu… | 2006 |
What descends from it? (5)
2 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 14 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 8 of the 62 ancestors have a recall of any class.
- Of its descendants, K160158 (Nobel Biocare AB, 2016) has gone furthest, with 3 descendants of its own.
- 7 other devices also cite its predicate K090069.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 NobelProcera 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091907 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091907: Nobelprocera 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/K091907
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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