510(k) · Cleared
ClearedProcera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobel Biocare Uas, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Oct 20, 2004 as substantially equivalent to K031719 (Nobel Biocare AB, 2003) and 5 other predicates after a 22-day review. Its family tree reaches back 6 generations to 1995. 441 later devices descend from it.
- Decided
- Oct 20, 2004
- Review
- 22 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 6 generations to K944964 (1995). 38 ancestors in all, the oldest K871863 (1987). 441 later devices descend from it, 10 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 deviceK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
- Descendant · cites it directly · 278 of its ownK091756 Nobelprocera TI AbutmentNobel Biocare AB · 2009
- Descendant · cites it directly · 261 of its ownK052070 Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia…Atlantis Components, Inc. · 2005
- Descendant · 2 generations on · 240 of its ownK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
- Descendant · 2 generations on · 200 of its ownK093780 Atlantis Abutment for Dentsply Implant, Atlantis Gemini Abutment…Astra Tech, Inc. · 2010
- Descendant · 3 generations on · 199 of its ownK101004 Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini…Astra Tech, Inc. · 2010
Showing 5 of 441 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 441 · See all- K091756Nobelprocera TI AbutmentNobel Biocare AB · 2009 · cites it directly278descendants
- K052070Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis Gemeini +…Atlantis Components, Inc. · 2005 · cites it directly261descendants
- K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010 · 2 generations on240descendants
- K093780Atlantis Abutment for Dentsply Implant, Atlantis Gemini Abutment, Atlantis Gemini +…Astra Tech, Inc. · 2010 · 2 generations on200descendants
- K101004Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment, Atlantis…Astra Tech, Inc. · 2010 · 3 generations on199descendants
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) | K042658 | Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004… | Nobel Biocare Uas, Inc. | 2004 | — |
| +1 | K091756 | Nobelprocera TI Abutment | Nobel Biocare AB | 2009 | — |
| +1 | K052070 | Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis… | Atlantis Components, Inc. | 2005 | — |
| +2 | K100152 | Sirona Cad/Cam System | Sirona Dental Systems GmbH | 2010 | — |
| +2 | K093780 | Atlantis Abutment for Dentsply Implant, Atlantis Gemini Abutment, Atlantis… | Astra Tech, Inc. | 2010 | — |
| +3 | K101004 | Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment… | Astra Tech, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 8 | 0 |
| 1994 | 7 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 5 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 8 | 0 |
| 2010 | 5 | 0 |
| 2011 | 9 | 0 |
| 2012 | 10 | 0 |
| 2013 | 8 | 0 |
| 2014 | 19 | 0 |
| 2015 | 24 | 0 |
| 2016 | 24 | 0 |
| 2017 | 21 | 0 |
| 2018 | 21 | 0 |
| 2019 | 21 | 0 |
| 2020 | 36 | 0 |
| 2021 | 31 | 0 |
| 2022 | 31 | 0 |
| 2023 | 41 | 0 |
| 2024 | 54 | 0 |
| 2025 | 41 | 0 |
| 2026 | 23 | 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? (7)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031719 | Esthetic Zirconia AbutmentSummary page 1…872.3630) Trade or Proprietary or Model Name: Procera® Abutment BrAnemark Legally Marketed Device(s): Esthetic Zirconia Abutment (K031719) Procera® Abutment System (K974150) Ceramic Abu… | 2003 |
| * | K974150 | Procera Preparable Abutment SystemSummary page 1…cera® Abutment BrAnemark Legally Marketed Device(s): Esthetic Zirconia Abutment (K031719) Procera® Abutment System (K974150) Ceramic Abutment (K913255) 3i Dental Abutment… | 1998 |
| * | K913255 | Ceramic (TM) AbutmentSummary page 1…thetic Zirconia Abutment (K031719) Procera® Abutment System (K974150) Ceramic Abutment (K913255) 3i Dental Abutment (K032263) Restore Self-Tapp… | 1994 |
| * | K032263 | 3I Patient-Specific Dental Abutment and Overdenture BarSummary page 1…Procera® Abutment System (K974150) Ceramic Abutment (K913255) 3i Dental Abutment (K032263) Restore Self-Tapping Dental Implant System (K954512)… | 2004 |
| * | K954512 | Restore Self Tapping Dental Implant SystemSummary page 1…ment (K913255) 3i Dental Abutment (K032263) Restore Self-Tapping Dental Implant System (K954512) Taperlock Dental Implant System (KO011038) Ste… | 1996 |
| Kept off the family tree | K001038 | Taperlock Dental Implant System Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree | |
| * | K981516 | Sterngold Implamed Hex Screw Implant TPS Coated Sterngold Implamed Hex Screw Implant HA…Summary page 1…tem (K954512) Taperlock Dental Implant System (KO011038) Stemgold ImplaMed Hex Implant (K981516) Device Description: The Procera® Abutment Brinemark is an artificial tooth abutment designed to fit and function on root-form e… | 1998 |
What descends from it? (441)
See all 44110 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091756 | Nobelprocera TI Abutment | 2009 | 278 |
| K052070 | Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis Gemeini +… | 2005 | 261 |
| K083192 | Inclusive Titanium Abutment Blanks | 2009 | 40 |
| K091904 | Nobelprocera ZI Abutment | 2009 | 35 |
| K061478 | Procera Titanium Abutment for Astratech and Camlog Implant Systems | 2006 | 33 |
| K103252 | Camlog Vario SR Abutments | 2011 | 32 |
| K061529 | Procera Zirconia Abutment for Camlog Implant System | 2006 | 26 |
| K052823 | Implantium Abutments | 2006 | 21 |
| K051501 | Zirace | 2005 | 8 |
| K073217 | Inclusive Implant Abutments | 2008 | 3 |
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 3 companies; a new generation was cleared every 10 months on median.
- 5 of the 38 ancestors have a recall of any class.
- Of its descendants, K091756 (Nobel Biocare AB, 2009) has gone furthest, with 278 descendants of its own.
- 8 other devices also cite its predicate K031719.
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® Abutment Brinemark is indicated for the treatment of partially edentulous patients requiring a prosthetic device. In addition to the BrAnemark implant, the abutment's hexagon connector fits the external hexagon of the following endosseous implants:
- 3® 3.75
- Lifecore® Biomedical Restore 3.75
- Zimmere Dental Taperlock 4.0
- Stemgold Implamed® 3.75
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042658 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042658: Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042658
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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