510(k) · Cleared
ClearedProcera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052
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 Nov 18, 2004 as substantially equivalent to K041236 (Nobel Biocare AB, 2004) and 4 other predicates after a 14-day review. Its family tree reaches back 6 generations to 1995. 327 later devices descend from it.
- Decided
- Nov 18, 2004
- Review
- 14 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K944964 (1995). 59 ancestors in all, the oldest K871863 (1987). 327 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 5 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 4 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 3 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 2 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 1 generation backK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
- This deviceK043042 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004
- Descendant · cites it directly · 313 of its ownK090069 Procera Implant Bridge OverdentureNobel Biocare AB · 2009
- Descendant · 2 generations on · 278 of its ownK091756 Nobelprocera TI AbutmentNobel Biocare AB · 2009
- Descendant · 3 generations on · 240 of its ownK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
- Descendant · 2 generations on · 167 of its ownK101465 Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010
- Descendant · 3 generations on · 165 of its ownK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
Showing 5 of 327 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 327 · See all- K090069Procera Implant Bridge OverdentureNobel Biocare AB · 2009 · cites it directly313descendants
- K091756Nobelprocera TI AbutmentNobel Biocare AB · 2009 · 2 generations on278descendants
- K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010 · 3 generations on240descendants
- K101465Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010 · 2 generations on167descendants
- K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG · 2012 · 3 generations on165descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −5 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −4 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −3 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −2 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −1 | K032263 | 3I Patient-Specific Dental Abutment and Overdenture Bar | Implant Innovations, Inc. | 2004 | 1 |
| 0 (this device) | K043042 | Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 | Nobel Biocare AB | 2004 | — |
| +1 | K090069 | Procera Implant Bridge Overdenture | Nobel Biocare AB | 2009 | — |
| +2 | K091756 | Nobelprocera TI Abutment | Nobel Biocare AB | 2009 | — |
| +3 | K100152 | Sirona Cad/Cam System | Sirona Dental Systems GmbH | 2010 | — |
| +2 | K101465 | Straumann Cares Bridge; Straumann Cares Dolder Bar | Institut Straumann AG | 2010 | — |
| +3 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 7 | 0 |
| 2013 | 5 | 0 |
| 2014 | 14 | 0 |
| 2015 | 15 | 0 |
| 2016 | 19 | 0 |
| 2017 | 17 | 0 |
| 2018 | 16 | 0 |
| 2019 | 17 | 0 |
| 2020 | 30 | 0 |
| 2021 | 27 | 0 |
| 2022 | 25 | 0 |
| 2023 | 33 | 0 |
| 2024 | 41 | 0 |
| 2025 | 29 | 0 |
| 2026 | 17 | 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? (5)
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 |
|---|---|---|---|
| * | K041236 | Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Summary page 1…ent (21 CFR 872.3630) Trade or Proprietary or Model Name: Procera® Implant Bridge Legally Marketed Devices: Procera® Implant Bridge (K041236) 3i Dental Abutment (K032263) Restore Self-Tapping Dent… | 2004 |
| * | K032263 | 3I Patient-Specific Dental Abutment and Overdenture BarSummary page 1…Procera® Implant Bridge Legally Marketed Devices: Procera® Implant Bridge (K041236) 3i Dental Abutment (K032263) Restore Self-Tapping Dental Implant System (K954512) T… | 2004 |
| * | K954512 | Restore Self Tapping Dental Implant SystemSummary page 1…plant Bridge (K041236) 3i Dental Abutment (K032263) Restore Self-Tapping Dental Implant System (K954512) Taper-lock Dental Implant System (K011038) Sterngold I… | 1996 |
| * | K011038 | Taper-Lock Dental Implant SystemSummary page 1…K032263) Restore Self-Tapping Dental Implant System (K954512) Taper-lock Dental Implant System (K011038) Sterngold ImplaMed Hex Implant (K981516) Device Description: Nobel Biocare's Procera® Im… | 2001 |
| * | K981516 | Sterngold Implamed Hex Screw Implant TPS Coated Sterngold Implamed Hex Screw Implant HA…Summary page 1…ant System (K954512) Taper-lock Dental Implant System (K011038) Sterngold ImplaMed Hex Implant (K981516) Device Description: Nobel Biocare's Procera® Implant Bridge is a bridge framework that attaches to implants or abutments. The… | 1998 |
What descends from it? (327)
See all 3274 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 9 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 8 of the 59 ancestors have a recall of any class.
- Of its descendants, K090069 (Nobel Biocare AB, 2009) has gone furthest, with 313 descendants of its own.
- 3 other devices also cite its predicate K041236.
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 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 the Branemark implant, the bridge's hexagon connector interface fits the external hexagon of the following endosseous implants:
* 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/K043042 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043042: Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043042
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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