510(k) · Cleared
ClearedProcera Abutment Octagon
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 May 27, 2004 as substantially equivalent to K031719 (Nobel Biocare AB, 2003) and 2 other predicates after a 15-day review. Its family tree reaches back 5 generations to 1990. 61 later devices descend from it.
- Decided
- May 27, 2004
- Review
- 15 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K894844 (1990). 27 ancestors in all. 61 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 4 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 3 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 2 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 1 generation backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- This deviceK041275 Procera Abutment OctagonNobel Biocare Uas, Inc. · 2004
- Descendant · cites it directly · 33 of its ownK061478 Procera Titanium Abutment for Astratech and Camlog Implant SystemsNobel Biocare AB · 2006
- Descendant · 2 generations on · 32 of its ownK103252 Camlog Vario SR AbutmentsAltatec GmbH · 2011
- Descendant · cites it directly · 26 of its ownK061529 Procera Zirconia Abutment for Camlog Implant SystemNobel Biocare AB · 2006
- Descendant · 2 generations on · 25 of its ownK132125 A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014
- Descendant · 3 generations on · 16 of its ownK121334 VarioecoThommen Medical AG · 2012
Showing 5 of 61 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 61 · See all- K061478Procera Titanium Abutment for Astratech and Camlog Implant SystemsNobel Biocare AB · 2006 · cites it directly33descendants
- K103252Camlog Vario SR AbutmentsAltatec GmbH · 2011 · 2 generations on32descendants
- K061529Procera Zirconia Abutment for Camlog Implant SystemNobel Biocare AB · 2006 · cites it directly26descendants
- K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014 · 2 generations on25descendants
- K121334VarioecoThommen Medical AG · 2012 · 3 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −4 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −3 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −2 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −1 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| 0 (this device) | K041275 | Procera Abutment Octagon | Nobel Biocare Uas, Inc. | 2004 | — |
| +1 | K061478 | Procera Titanium Abutment for Astratech and Camlog Implant Systems | Nobel Biocare AB | 2006 | — |
| +2 | K103252 | Camlog Vario SR Abutments | Altatec GmbH | 2011 | — |
| +1 | K061529 | Procera Zirconia Abutment for Camlog Implant System | Nobel Biocare AB | 2006 | — |
| +2 | K132125 | A.B. Dental Devices Dental Implants System | A.B. Dental Devices, Ltd. | 2014 | — |
| +3 | K121334 | Varioeco | Thommen Medical AG | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 8 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 6 | 0 |
| 2024 | 8 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K031719 | Esthetic Zirconia Abutment | 2003 |
| * | K971706 | Tiadapt Abutment SystemSummary page 1…rocera®~ Abutment Octagon Legally Marketed Device(s): Esthetic Zirconia Abutment (KO31 719) TiAdapt Abutment System (K971 706) ITI synOcta Meso Abutments (K033243) Device Description: The Procera® Abutment Octago… | 1997 |
| * | K033243 | Iti Synocta Meso AbutmentsSummary page 1…rconia Abutment (KO31 719) TiAdapt Abutment System (K971 706) ITI synOcta Meso Abutments (K033243) Device Description: The Procera® Abutment Octagon is an artificial tooth abutment designed to fit and function on the Straumn… | 2003 |
What descends from it? (61)
See all 613 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 14 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 27 ancestors has a recall of any class.
- Of its descendants, K061478 (Nobel Biocare AB, 2006) has gone furthest, with 33 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 Octagon is indicated for the treatment of partially edentulous patients requiring prosthetic devices that fit Straumann regular neck 4.8mm endosseous implants in order to restore chewing function.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041275 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041275: Procera Abutment Octagon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041275
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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