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 Sep 1, 2023 as substantially equivalent to K201860 (Elos Medtech Pinol A/S, 2021) after a 207-day review. Its family tree reaches back 19 generations to 1996. 4 later devices descend from it.
- Decided
- Sep 1, 2023
- Review
- 207 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 19 generations to K960026 (1996). 320 ancestors in all, the oldest K781060 (1978). 4 later devices descend from it, 2 citing it directly.
- Root · 19 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 15 generations between
- 3 generations backK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- 2 generations backK191919 Elos Accurate Hybrid BaseElos Medtech Pinol A/S · 2020
- 1 generation backK201860 Elos Accurate Hybrid BaseElos Medtech Pinol A/S · 2021
- This deviceK230317 Elos Accurate Hybrid BaseElos Medtech Pinol A/S · 2023
- Descendant · cites it directly · 2 of its ownK242025 Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S · 2024
- Descendant · 2 generations on · 0 of its ownK261327 Elos Accurate Hybrid BaseElos Medtech Pinol A/S · 2026
- Descendant · 2 generations on · 0 of its ownK251497 Elos Accurate Hybrid BaseElos Medtech Pinol A/S · 2025
- Descendant · cites it directly · 0 of its ownK241722 Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S · 2024
Show all 19 generations
- Root · 19 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 18 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 17 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 16 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 15 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 14 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 13 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 12 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 11 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 10 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 9 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 8 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 7 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 6 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- 5 generations backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 4 generations backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- 3 generations backK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- 2 generations backK191919 Elos Accurate Hybrid BaseElos Medtech Pinol A/S · 2020
- 1 generation backK201860 Elos Accurate Hybrid BaseElos Medtech Pinol A/S · 2021
- This deviceK230317 Elos Accurate Hybrid BaseElos Medtech Pinol A/S · 2023
Most influential descendants
Showing 4 of 4 · See all- K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S · 2024 · cites it directly2descendants
- K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S · 2026 · 2 generations on0descendants
- K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S · 2025 · 2 generations on0descendants
- K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −18 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −17 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −16 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −15 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −14 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −13 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −12 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −11 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −10 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −9 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −8 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| −7 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| −6 | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart… | Neodent USA, Inc. | 2014 | — |
| −5 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| −4 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| −3 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
| −2 | K191919 | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | 2020 | — |
| −1 | K201860 | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | 2021 | — |
| 0 (this device) | K230317 | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | 2023 | — |
| +1 | K242025 | Elos Accurate® Hybrid Base™ | Elos Medtech Pinol A/S | 2024 | — |
| +2 | K261327 | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | 2026 | — |
| +2 | K251497 | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | 2025 | — |
| +1 | K241722 | Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment | Elos Medtech Pinol A/S | 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 |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 1 | 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 30.7 · 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 |
|---|---|---|---|
| * | K201860 | 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: • K201860 / SE 02/19/2021 - Elos Accurate® Hybrid Base™… | 2021 |
| † | K191919 | Elos Accurate Hybrid Base | 2020 |
| † | K222044 | Elos Accurate Customized Abutment | 2022 |
| † | K013227 | Screw Vent Implant; Tapered Screw Vent Implant | 2001 |
| † | K122300 | T3 Dental Implant | 2013 |
| † | K163194 | Neodent Implant System - GM Line | 2017 |
| † | K180536 | Neodent Implant System – GM Line | 2018 |
| † | K201225 | Neodent Implant System - GM Helix Implants 7.0 | 2020 |
| † | K140934 | Hiossen Implant System | 2014 |
| † | K153332 | ETIII SA Fixture System (O3.2mm) | 2016 |
| † | K150938 | Straumann® Dental Implant System ¿ Roxolid® SLA Implants | 2015 |
What descends from it? (4)
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 27 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 43 of the 320 ancestors have a recall of any class.
- Of its descendants, K242025 (Elos Medtech Pinol A/S, 2024) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K201860.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 (183 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.
Zimmer Screw-vent 3.5; Zimmer Screw-vent 4.5; Zimmer Screw-vent 5.7; Biomet 3i Certain 3.4; Biomet 3i Certain 4.1; Biomet 3i Certain 5.0; Biomet 3i Certain 6.0; Straumann Standard RN; Straumann Standard WN; Neodent GM; Hiossen ET Mini; Hiossen ET Regular.
The zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are either intended to be sent and manufactured at an FDA registered Elos Medtech approved milling facility or 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K230317 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230317: Elos Accurate Hybrid Base.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230317
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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