510(k) · Cleared
ClearedElos Accurate Hybrid Base
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elos Medtech Pinol A/S · NHA Abutment, Implant, Dental, Endosseous
Cleared on Feb 19, 2021 as substantially equivalent to K191919 (Elos Medtech Pinol A/S, 2020) after a 228-day review. Its family tree reaches back 18 generations to 1996. 10 later devices descend from it.
- Decided
- Feb 19, 2021
- Review
- 228 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 18 generations to K960026 (1996). 319 ancestors in all, the oldest K781060 (1978). 10 later devices descend from it, 2 citing it directly.
- Root · 18 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 14 generations between
- 3 generations backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- 2 generations backK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- 1 generation backK191919 Elos Accurate Hybrid BaseElos Medtech Pinol A/S · 2020
- This deviceK201860 Elos Accurate Hybrid BaseElos Medtech Pinol A/S · 2021
- Descendant · cites it directly · 4 of its ownK230317 Elos Accurate Hybrid BaseElos Medtech Pinol A/S · 2023
- Descendant · cites it directly · 4 of its ownK222215 IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L. · 2022
- Descendant · 2 generations on · 3 of its ownK231413 IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L. · 2023
- Descendant · 2 generations on · 2 of its ownK242025 Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S · 2024
- Descendant · 3 generations on · 2 of its ownK240570 IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L. · 2024
Show all 18 generations
- Root · 18 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 17 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 16 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 15 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 14 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 13 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 12 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 11 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 10 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 9 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 8 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 7 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 6 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 5 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- 4 generations backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 3 generations backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- 2 generations backK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- 1 generation backK191919 Elos Accurate Hybrid BaseElos Medtech Pinol A/S · 2020
- This deviceK201860 Elos Accurate Hybrid BaseElos Medtech Pinol A/S · 2021
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S · 2023 · cites it directly4descendants
- K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L. · 2022 · cites it directly4descendants
- K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L. · 2023 · 2 generations on3descendants
- K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S · 2024 · 2 generations on2descendants
- K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L. · 2024 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −17 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −16 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −15 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −14 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −13 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −12 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −11 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −10 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −9 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −8 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −7 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| −6 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| −5 | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart… | Neodent USA, Inc. | 2014 | — |
| −4 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| −3 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| −2 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
| −1 | K191919 | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | 2020 | — |
| 0 (this device) | K201860 | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | 2021 | — |
| +1 | K230317 | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | 2023 | — |
| +1 | K222215 | IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. | 2022 | — |
| +2 | K231413 | IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. | 2023 | — |
| +2 | K242025 | Elos Accurate® Hybrid Base™ | Elos Medtech Pinol A/S | 2024 | — |
| +3 | K240570 | IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 7 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 12 | 0 |
| 1994 | 12 | 0 |
| 1995 | 15 | 0 |
| 1996 | 16 | 0 |
| 1997 | 7 | 0 |
| 1998 | 8 | 0 |
| 1999 | 11 | 0 |
| 2000 | 11 | 0 |
| 2001 | 18 | 0 |
| 2002 | 19 | 0 |
| 2003 | 17 | 0 |
| 2004 | 16 | 0 |
| 2005 | 14 | 0 |
| 2006 | 17 | 0 |
| 2007 | 23 | 0 |
| 2008 | 14 | 0 |
| 2009 | 13 | 0 |
| 2010 | 10 | 0 |
| 2011 | 10 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K191919 | Elos Accurate Hybrid BaseSummary page 4…ials and Indications for Use of the subject devices ai·e substantially equivalent to the predicate devices noted below. Primary Predicate Device: • K191919 / SE 02/10/2020 - Elos Accurate® Hybrid Base™ Reference Devices: • K180899 / SE 11/01/2018 Universal Base Abutment… | 2020 |
| † | K180899 | Universal Base Abutment | 2018 |
| † | K171799 | Elos Accurate Customized Abutment, Elos Prosthetic Screw | 2018 |
| † | K130436 | Multilink Hybrid Abutment Cement | 2013 |
| † | K151455 | 3Shape Abutment Designer Software | 2016 |
| † | K964739 | Steri-Oss Tiodized Screw | 1997 |
| † | K011394 | Lava Frame, Lava Frame Shade, Lava Ceram | 2001 |
What descends from it? (10)
2 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 25 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 43 of the 319 ancestors have a recall of any class.
- Of its descendants, K230317 (Elos Medtech Pinol A/S, 2023) has gone furthest, with 4 descendants of its own.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using a prosthetic screw and attached to the zirconia superstructure by cementing. The Elos Accurate® Hybrid Base™ is compatible with the implant systems listed in table…
Read the full statement (315 words)
The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using a prosthetic screw and attached to the zirconia superstructure by cementing.
The Elos Accurate® Hybrid Base™ is compatible with the implant systems listed in table 1:
Table 1.
Implant Platform compatibility — Platform diameter [mm] — Implant Body diameter [mm]
Nobel Replace NP — 3.5 — 3.5
Nobel Replace RP — 4.3 — 4.3
Nobel Replace WP — 5 — 5
Nobel Replace 6.0 — 6 — 6
Nobel CC 3.0 — 3 — 3
Nobel CC NP — 3.5 — 3.5 & 3.75
Nobel CC RP — 3.9 — 4.3 & 5
Nobel CC WP — 5.1 — 5.5
Straumann Bone Level NC — 3.3 — 3.3
Straumann Bone Level RC — 4.1 & 4.8 — 4.1 & 4.8
Astra Tech 3.0 — 3 — 3
Astra Tech 3.5/4.0 — 3.5 & 4 — 3.5 & 4
Astra Tech 4.5/5.0 — 4.5 & 5 — 4.5 & 5
Astra Tech EV 3.0 — 3 — 3
Astra Tech EV 3.6 — 3.6 — 3.6
Astra Tech EV 4.2 — 4.2 — 3.6 & 4.2
Astra Tech EV 4.8 — 4.8 — 4.2 & 4.8
Astra Tech EV 5.4 — 5.4 — 5.4
Brånemark NP — 3.5 — 3.3
Brånemark RP — 4.1 — 3.75, 4 & 5
Brånemark WP — 5.1 — 5&6
The zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are only intended to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201860 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201860: Elos Accurate Hybrid Base.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201860
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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