510(k) · Cleared
ClearedNobelProcera HT ML FCZ Implant Bridge and Framework
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 Jul 25, 2016 as substantially equivalent to K091907 (Nobel Biocare AB, 2009) and 1 other predicate after a 180-day review. Its family tree reaches back 9 generations to 1995. 3 later devices descend from it.
- Decided
- Jul 25, 2016
- Review
- 180 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K944964 (1995). 64 ancestors in all, the oldest K871863 (1987). 3 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 5 generations between
- 3 generations backK043042 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004
- 2 generations backK053091 Procera Implant Bridge ZirconiaNobel Biocare AB · 2006
- 1 generation backK091907 Nobelprocera Implant Bridge ZirconiaNobel Biocare AB · 2009
- This deviceK160158 NobelProcera HT ML FCZ Implant Bridge and FrameworkNobel Biocare AB · 2016
- Descendant · cites it directly · 2 of its ownK202452 NobelProcera Zirconia Implant BridgeNobel Biocare AB · 2020
- Descendant · 2 generations on · 0 of its ownK253999 Universal Base ASC Engaging; Universal Base ASC Non-Engaging…Nobel Biocare AB · 2026
- Descendant · 2 generations on · 0 of its ownK240346 NobelProcera Zirconia Implant BridgeNobel Biocare AB · 2025
Show all 9 generations
- Root · 9 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 8 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 7 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 6 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 5 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 4 generations backK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
- 3 generations backK043042 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004
- 2 generations backK053091 Procera Implant Bridge ZirconiaNobel Biocare AB · 2006
- 1 generation backK091907 Nobelprocera Implant Bridge ZirconiaNobel Biocare AB · 2009
- This deviceK160158 NobelProcera HT ML FCZ Implant Bridge and FrameworkNobel Biocare AB · 2016
Most influential descendants
Showing 3 of 3 · See all- K202452NobelProcera Zirconia Implant BridgeNobel Biocare AB · 2020 · cites it directly2descendants
- K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…Nobel Biocare AB · 2026 · 2 generations on0descendants
- K240346NobelProcera Zirconia Implant BridgeNobel Biocare AB · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −8 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −7 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −6 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −5 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −4 | K032263 | 3I Patient-Specific Dental Abutment and Overdenture Bar | Implant Innovations, Inc. | 2004 | 1 |
| −3 | K043042 | Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 | Nobel Biocare AB | 2004 | — |
| −2 | K053091 | Procera Implant Bridge Zirconia | Nobel Biocare AB | 2006 | — |
| −1 | K091907 | Nobelprocera Implant Bridge Zirconia | Nobel Biocare AB | 2009 | — |
| 0 (this device) | K160158 | NobelProcera HT ML FCZ Implant Bridge and Framework | Nobel Biocare AB | 2016 | — |
| +1 | K202452 | NobelProcera Zirconia Implant Bridge | Nobel Biocare AB | 2020 | — |
| +2 | K253999 | Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base… | Nobel Biocare AB | 2026 | — |
| +2 | 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 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 30.6 · 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? (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 |
|---|---|---|---|
| * | K091907 | Nobelprocera Implant Bridge ZirconiaSummary page 4…Implant Abutment (21 CFR 872.3640) Regulatory Class: II Product Code: NHA III. PREDICATE DEVICE Nobel Biocare – NobelProcera Implant Bridge Zirconia (K091907) Nobel Biocare – Angulated Screw Channel Abutment Conical Connection (K132746) IV. DEVICE DESCRIPTION The NobelPro… | 2009 |
| * | K132746 | Nobelprocera Angulated Screw Channel Abutment Conical ConnectionSummary page 4…III. PREDICATE DEVICE Nobel Biocare – NobelProcera Implant Bridge Zirconia (K091907) Nobel Biocare – Angulated Screw Channel Abutment Conical Connection (K132746) IV. DEVICE DESCRIPTION The NobelProcera HT ML FCZ Implant Bridge and Framework is an individualized implant suppo… | 2014 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202452 | NobelProcera Zirconia Implant Bridge | 2020 | 2 |
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 21 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 9 of the 64 ancestors have a recall of any class.
- Of its descendants, K202452 (Nobel Biocare AB, 2020) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K091907.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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® HT ML FCZ (full contour zirconia) and framework Implant Bridge are indicated for use as a bridge anatomically shaped and/or framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K160158 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160158: NobelProcera HT ML FCZ Implant Bridge and Framework.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160158
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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