510(k) · Cleared
ClearedNobelprocera Peek Abutments
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 Jun 5, 2013 as substantially equivalent to K925766 (Nobelpharma USA, Inc., 1994) and 1 other predicate after a 432-day review. Its family tree reaches back 3 generations to 1989. 105 later devices descend from it.
- Decided
- Jun 5, 2013
- Review
- 432 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K891615 (1989). 8 ancestors in all. 105 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK891615 Surgical DrillsImplant Innovations International, Inc. · 1989
- 2 generations backK962014 3I Single Use, Disposable Drills,Taps,Burs, Etc.Implant Innovations, Inc. · 1996
- 1 generation backK043195 Neo Implant SystemNeoss, Ltd. · 2005
- This deviceK120954 Nobelprocera Peek AbutmentsNobel Biocare AB · 2013
- Descendant · cites it directly · 101 of its ownK133731 Nobelactive Wide Platform (WP)Nobel Biocare AB · 2014
- Descendant · 2 generations on · 99 of its ownK142260 NobelActiveNobel Biocare AB · 2015
- Descendant · 3 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- Descendant · 3 generations on · 51 of its ownK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- Descendant · 4 generations on · 38 of its ownK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
Showing 5 of 105 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 105 · See all- K133731Nobelactive Wide Platform (WP)Nobel Biocare AB · 2014 · cites it directly101descendants
- K142260NobelActiveNobel Biocare AB · 2015 · 2 generations on99descendants
- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 3 generations on86descendants
- K173908DESS Dental Smart SolutionsTerrats Medical SL · 2018 · 3 generations on51descendants
- K191986DESS Dental Smart SolutionsTerrats Medical SL · 2019 · 4 generations on38descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K891615 | Surgical Drills | Implant Innovations International, Inc. | 1989 | — |
| −2 | K962014 | 3I Single Use, Disposable Drills,Taps,Burs, Etc. | Implant Innovations, Inc. | 1996 | — |
| −1 | K043195 | Neo Implant System | Neoss, Ltd. | 2005 | — |
| 0 (this device) | K120954 | Nobelprocera Peek Abutments | Nobel Biocare AB | 2013 | — |
| +1 | K133731 | Nobelactive Wide Platform (WP) | Nobel Biocare AB | 2014 | — |
| +2 | K142260 | NobelActive | Nobel Biocare AB | 2015 | — |
| +3 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| +3 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
| +4 | K191986 | DESS Dental Smart Solutions | Terrats Medical SL | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 8 | 0 |
| 2020 | 6 | 0 |
| 2021 | 10 | 0 |
| 2022 | 11 | 0 |
| 2023 | 14 | 0 |
| 2024 | 14 | 0 |
| 2025 | 22 | 0 |
| 2026 | 13 | 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? (2)
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 |
|---|---|---|---|
| * | K925766 | Branemark System Temporary SolutionsSummary page 1…t (21 CFR 872.3630) Product Code: NHA Trade or Proprietary or Model Name: NobelProcera PEEK Abutments Legally Marketed Device(s): Branemark System Temporary Solutions (K925766) Neo Implant System (K043195) Device Description: : NobelProcera PEEK Abutments are endosseous dental implant abutments. They a… | 1994 |
| * | K043195 | Neo Implant SystemSummary page 1…ode: NHA Trade or Proprietary or Model Name: NobelProcera PEEK Abutments Legally Marketed Device(s): Branemark System Temporary Solutions (K925766) Neo Implant System (K043195) Device Description: : NobelProcera PEEK Abutments are endosseous dental implant abutments. They are made from PEEK in natural… | 2005 |
What descends from it? (105)
See all 1054 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 24 years and passes through 4 companies; a new generation was cleared every 8.2 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K133731 (Nobel Biocare AB, 2014) has gone furthest, with 101 descendants of its own.
- 12 other devices also cite its predicate K925766.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 Nobel Biocare PEEK Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K120954 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120954: Nobelprocera Peek Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120954
Report an extraction error
Are you the manufacturer?
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