510(k) · Cleared
ClearedProcera Titanium Abutment for Astratech and Camlog Implant Systems
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 21, 2006 as substantially equivalent to K041275 (Nobel Biocare Uas, Inc., 2004) and 3 other predicates after an 83-day review. Its family tree reaches back 7 generations to 1995. 33 later devices descend from it.
- Decided
- Aug 21, 2006
- Review
- 83 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K944964 (1995). 49 ancestors in all, the oldest K871863 (1987). 33 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 deviceK061478 Procera Titanium Abutment for Astratech and Camlog Implant SystemsNobel Biocare AB · 2006
- Descendant · cites it directly · 32 of its ownK103252 Camlog Vario SR AbutmentsAltatec GmbH · 2011
- Descendant · 2 generations on · 16 of its ownK121334 VarioecoThommen Medical AG · 2012
- Descendant · 3 generations on · 15 of its ownK160244 VARIOuniteThommen Medical AG · 2016
- Descendant · 2 generations on · 14 of its ownK113779 Conelog Implant SystemAltatec GmbH · 2012
- Descendant · 4 generations on · 13 of its ownK163634 External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · Recalled
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K103252Camlog Vario SR AbutmentsAltatec GmbH · 2011 · cites it directly32descendants
- K121334VarioecoThommen Medical AG · 2012 · 2 generations on16descendants
- K160244VARIOuniteThommen Medical AG · 2016 · 3 generations on15descendants
- K113779Conelog Implant SystemAltatec GmbH · 2012 · 2 generations on14descendants
- K163634External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · 4 generations on13descendants
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) | K061478 | Procera Titanium Abutment for Astratech and Camlog Implant Systems | Nobel Biocare AB | 2006 | — |
| +1 | K103252 | Camlog Vario SR Abutments | Altatec GmbH | 2011 | — |
| +2 | K121334 | Varioeco | Thommen Medical AG | 2012 | — |
| +3 | K160244 | VARIOunite | Thommen Medical AG | 2016 | — |
| +2 | K113779 | Conelog Implant System | Altatec GmbH | 2012 | — |
| +4 | K163634 | External Hex Implants | Southern Implants (Pty), Ltd. | 2017 | 1 |
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 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 6 | 0 |
| 2024 | 5 | 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? (4)
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…r Model Name: Procera Titanium Abutment for AstraTech and Camlog Implant Systems Legally Marketed Device(s): Procera Abutment Octagon (K(041275) Procera Abutment Br~nemark (1(042658) AstraTech Fixtur… | 2004 |
| * | K042658 | Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004Summary page 1…h and Camlog Implant Systems Legally Marketed Device(s): Procera Abutment Octagon (K(041275) Procera Abutment Br~nemark (1(042658) AstraTech Fixture MicroThread OsseoSpeed (K053384) Alt… | 2004 |
| * | K053384 | Fixature Microthread Osseospeed, a Component of the Astra Tech Implant SystemSummary page 1…agon (K(041275) Procera Abutment Br~nemark (1(042658) AstraTech Fixture MicroThread OsseoSpeed (K053384) Altatec; Camlog Screwline Implant System (K022425) Device Description: Nobel Biocare's Pr… | 2006 |
| * | K022425 | ScrewlineSummary page 1…8) AstraTech Fixture MicroThread OsseoSpeed (K053384) Altatec; Camlog Screwline Implant System (K022425) Device Description: Nobel Biocare's Procera Titanium Abutment for AstraTech and Camlog Implant Systems is fabricated to the ex… | 2002 |
What descends from it? (33)
See all 331 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103252 | Camlog Vario SR Abutments | 2011 | 32 |
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 49 ancestors have a recall of any class.
- Of its descendants, K103252 (Altatec GmbH, 2011) has gone furthest, with 32 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 Titanium Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation. Nobel Biocare's Procera Titanium Abutments fit the following endosseous implants:
- AstraTech 3.5, 4.0, 4.5, 5.0 mm
- 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/K061478 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061478: Procera Titanium Abutment for Astratech and Camlog Implant Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061478
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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