510(k) · Cleared
ClearedCore 3D Abutment System for Digital Prosthetic Solutions
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Core 3D Protech, S.L. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Oct 24, 2013 as substantially equivalent to K111935 (Nt-Trading GmbH and CO KG, 2012) and 3 other predicates after a 450-day review. Its family tree reaches back 13 generations to 1996. 29 later devices descend from it.
- Decided
- Oct 24, 2013
- Review
- 450 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 13 generations to K960026 (1996). 192 ancestors in all, the oldest K820013 (1982). 29 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 9 generations between
- 3 generations backK093321 Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc. · 2010 · Recalled
- 2 generations backK100985 Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc. · 2010
- 1 generation backK103291 Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc. · 2011
- This deviceK122295 Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L. · 2013
- Descendant · cites it directly · 26 of its ownK151621 BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc. · 2016
- Descendant · 2 generations on · 22 of its ownK183518 Preat AbutmentsPreat Corporation · 2019 · Recalled
- Descendant · 3 generations on · 8 of its ownK193096 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2020
- Descendant · 3 generations on · 6 of its ownK200817 URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020
- Descendant · 4 generations on · 5 of its ownK211921 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2021
Show all 13 generations
- Root · 13 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 12 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 11 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 10 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 9 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 8 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 7 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 6 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 5 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 4 generations backK052419 Maximus 3.0 and OS ImplantsBioHorizons Implant Systems, Inc. · 2005
- 3 generations backK093321 Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc. · 2010 · Recalled
- 2 generations backK100985 Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc. · 2010
- 1 generation backK103291 Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc. · 2011
- This deviceK122295 Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L. · 2013
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc. · 2016 · cites it directly26descendants
- K183518Preat AbutmentsPreat Corporation · 2019 · 2 generations on22descendants
- K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2020 · 3 generations on8descendants
- K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020 · 3 generations on6descendants
- K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2021 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −12 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −11 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −10 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −9 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −8 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −7 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −6 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −5 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −4 | K052419 | Maximus 3.0 and OS Implants | BioHorizons Implant Systems, Inc. | 2005 | — |
| −3 | K093321 | Biohorizons Laser-Lok 3.0 Implant System | BioHorizons Implant Systems, Inc. | 2010 | 1 |
| −2 | K100985 | Biohorizons Simple Solutions with Laser-Lok | BioHorizons Implant Systems, Inc. | 2010 | — |
| −1 | K103291 | Biohorizons Laser-Lok Abutments for Nobel Biocare | BioHorizons Implant Systems, Inc. | 2011 | — |
| 0 (this device) | K122295 | Core 3D Abutment System for Digital Prosthetic Solutions | Core 3D Protech, S.L. | 2013 | — |
| +1 | K151621 | BioHorizons CAD/CAM Abutments | BioHorizons Implant Systems, Inc. | 2016 | — |
| +2 | K183518 | Preat Abutments | Preat Corporation | 2019 | 3 |
| +3 | K193096 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2020 | — |
| +3 | K200817 | URIS OMNI Narrow System & Prosthetic | Truabutment, Inc. | 2020 | — |
| +4 | K211921 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 13 | 0 |
| 1994 | 13 | 0 |
| 1995 | 9 | 0 |
| 1996 | 14 | 0 |
| 1997 | 5 | 0 |
| 1998 | 7 | 0 |
| 1999 | 11 | 0 |
| 2000 | 8 | 0 |
| 2001 | 8 | 0 |
| 2002 | 12 | 0 |
| 2003 | 9 | 0 |
| 2004 | 10 | 0 |
| 2005 | 8 | 0 |
| 2006 | 10 | 0 |
| 2007 | 9 | 0 |
| 2008 | 8 | 0 |
| 2009 | 9 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 8 | 0 |
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K111935 | TI-Base Abutment, 1 Connect AbutmentSummary page 1…Endosseous Dental Implant Abutment CLASSIFICATION NAME: Endosseous Dental Implant Abutment (21 CFR 872.3630) PREDICATE DEViCE(S): NT-Trading (K1 11935) Biohorizons (K1 03291) Laser Lok for Nobel Biocare Inclusive Den… | 2012 |
| * | K103291 | Biohorizons Laser-Lok Abutments for Nobel BiocareSummary page 1…NAME: Endosseous Dental Implant Abutment (21 CFR 872.3630) PREDICATE DEViCE(S): NT-Trading (K1 11935) Biohorizons (K1 03291) Laser Lok for Nobel Biocare Inclusive Dental Solutions (K083192)… | 2011 |
| * | K083192 | Inclusive Titanium Abutment BlanksSummary page 1…NT-Trading (K1 11935) Biohorizons (K1 03291) Laser Lok for Nobel Biocare Inclusive Dental Solutions (K083192) 3M Lava Software (K062493) DEVICE DESCRIPTION: The proposed devices are dental implant abutments… | 2009 |
| * | K062493 | Lava SoftwareSummary page 1…Biohorizons (K1 03291) Laser Lok for Nobel Biocare Inclusive Dental Solutions (K083192) 3M Lava Software (K062493) DEVICE DESCRIPTION: The proposed devices are dental implant abutments intended to be placed into dental implants and to pmovide… | 2006 |
What descends from it? (29)
See all 292 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 17 years and passes through 2 companies; a new generation was cleared every 9 months on median.
- 25 of the 192 ancestors have a recall of any class.
- Of its descendants, K151621 (BioHorizons Implant Systems, Inc., 2016) has gone furthest, with 26 descendants of its own.
- 1 other device also cites its predicate K111935.
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 CORE 3D abutment system for digital prosthetic solutions are dental abutments placed into a dental implant to provide support for dental prosthetic restorations. The abutments include: - Titanium Bases to be attached to the underlying implant and upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutment; - Titanium Abutment Blanks with a pre-machined implant connection where the upper portion may be…
Read the full statement (168 words)
The CORE 3D abutment system for digital prosthetic solutions are dental abutments placed into a dental implant to provide support for dental prosthetic restorations. The abutments include:
- Titanium Bases to be attached to the underlying implant and upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutment;
- Titanium Abutment Blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques;
- Abutment Screws to permanently fix the abutments to the underlying implant.
Core 3D abutments are intended for use to support single-tooth (unit) and multiple-tooth (bridges and bars) prostheses, in the mandible or maxilla for functional and aesthetic restorations.
Core 3D abutments designed using CAD/CAM techniques must fulfill the Core 3D allowable range of design specifications and be provided as straight abutments only.
Core 3D abutments and are compatible for use with the following dental implants:
* Nobel Biocare Brånemark System (K022582, K934825)
* Zimmer Tapered Screwvent (K013227, K061410, K072589)
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/K122295 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122295: Core 3D Abutment System for Digital Prosthetic Solutions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122295
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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