510(k) · Cleared
ClearedProcera Zirconia Abutment for Camlog Implant System
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 Aug 23, 2006 as substantially equivalent to K041275 (Nobel Biocare Uas, Inc., 2004) and 2 other predicates after an 82-day review. Its family tree reaches back 7 generations to 1995. 26 later devices descend from it.
- Decided
- Aug 23, 2006
- Review
- 82 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K944964 (1995). 48 ancestors in all, the oldest K871863 (1987). 26 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 backK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
- This deviceK061529 Procera Zirconia Abutment for Camlog Implant SystemNobel Biocare AB · 2006
- Descendant · cites it directly · 25 of its ownK132125 A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014
- Descendant · 2 generations on · 14 of its ownK140440 Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014
- Descendant · 3 generations on · 7 of its ownK151909 Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016
- Descendant · 2 generations on · 4 of its ownK162482 A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd. · 2017
- Descendant · 3 generations on · 2 of its ownK183024 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014 · cites it directly25descendants
- K140440Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014 · 2 generations on14descendants
- K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016 · 3 generations on7descendants
- K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd. · 2017 · 2 generations on4descendants
- K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020 · 3 generations on2descendants
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 | K042658 | Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004… | Nobel Biocare Uas, Inc. | 2004 | — |
| 0 (this device) | K061529 | Procera Zirconia Abutment for Camlog Implant System | Nobel Biocare AB | 2006 | — |
| +1 | K132125 | A.B. Dental Devices Dental Implants System | A.B. Dental Devices, Ltd. | 2014 | — |
| +2 | K140440 | Noris Medical Dental Implants System | Noris Medical, Ltd. | 2014 | — |
| +3 | K151909 | Noris Medical Zygomatic Dental Implant System | Noris Medical, Ltd. | 2016 | — |
| +2 | K162482 | A.B. DENTAL DEVICES Dental Implants System | A.B. Dental Device, Ltd. | 2017 | — |
| +3 | K183024 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 8 | 0 |
| 1994 | 7 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K041275 | Procera Abutment OctagonSummary page 1…prietary or Model Name: Procera Titanium Abutment for Camlog Implant System Legally Marketed Device(s): Procera Abutment Octagon (K041275) Procera Abutment Br~nemark (K042658) Altatec C… | 2004 |
| * | K042658 | Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004Summary page 1…r Camlog Implant System Legally Marketed Device(s): Procera Abutment Octagon (K041275) Procera Abutment Br~nemark (K042658) Altatec Camlog Screwline Implant System (K022425) Device Description: Nobel Biocare's… | 2004 |
| * | K022425 | ScrewlineSummary page 1…(K041275) Procera Abutment Br~nemark (K042658) Altatec Camlog Screwline Implant System (K022425) Device Description: Nobel Biocare's Procera Zirconia Abutment for Camlog Implant System is fabricated to the exact shape, size… | 2002 |
What descends from it? (26)
See all 261 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132125 | A.B. Dental Devices Dental Implants System | 2014 | 25 |
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.
- 6 of the 48 ancestors have a recall of any class.
- Of its descendants, K132125 (A.B. Dental Devices, Ltd., 2014) has gone furthest, with 25 descendants of its own.
- 2 other devices also cite its predicate K041275.
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 Zirconia Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation. Nobel Biocare's Procera Zirconia Abutments fit the following endosseous implants:
- Camlog 3.3, 3.8, 4.3, 5.0, 6.0 mm
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061529 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061529: Procera Zirconia Abutment for Camlog Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061529
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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