510(k) · Cleared
ClearedElos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment
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 13, 2024 as substantially equivalent to K230317 (Elos Medtech Pinol A/S, 2023) after a 91-day review. Its family tree reaches back 20 generations to 1996.
- Decided
- Sep 13, 2024
- Review
- 91 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 20 generations to K960026 (1996). 321 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 20 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 16 generations between
- 3 generations backK191919 Elos Accurate Hybrid BaseElos Medtech Pinol A/S · 2020
- 2 generations backK201860 Elos Accurate Hybrid BaseElos Medtech Pinol A/S · 2021
- 1 generation backK230317 Elos Accurate Hybrid BaseElos Medtech Pinol A/S · 2023
- This deviceK241722 Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S · 2024
Show all 20 generations
- Root · 20 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 19 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 18 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 17 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 16 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 15 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 14 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 13 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 12 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 11 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 10 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 9 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 8 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 7 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- 6 generations backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 5 generations backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- 4 generations backK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- 3 generations backK191919 Elos Accurate Hybrid BaseElos Medtech Pinol A/S · 2020
- 2 generations backK201860 Elos Accurate Hybrid BaseElos Medtech Pinol A/S · 2021
- 1 generation backK230317 Elos Accurate Hybrid BaseElos Medtech Pinol A/S · 2023
- This deviceK241722 Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −19 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −18 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −17 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −16 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −15 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −14 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −13 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −12 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −11 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −10 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −9 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| −8 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| −7 | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart… | Neodent USA, Inc. | 2014 | — |
| −6 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| −5 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| −4 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
| −3 | K191919 | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | 2020 | — |
| −2 | K201860 | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | 2021 | — |
| −1 | K230317 | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | 2023 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K230317 | Elos Accurate Hybrid BaseSummary page 6…erials and Indications for Use of the subject devices are substantially equivalent to the predicate device noted below. Primary Predicate Device: • K230317 / SE 09/01/2023 - Elos Accurate® Hybrid Base™ Reference Devices: • K231307 / SE 12/21/2023 - Elos Accurate® Custom… | 2023 |
| † | K231307 | Elos Accurate Customized Abutment | 2023 |
| † | K151455 | 3Shape Abutment Designer Software | 2016 |
| † | K173961 | Straumann BLX Implant System | 2018 |
| † | K181703 | Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments | 2018 |
| † | K191256 | Straumann BLX Ø3.5 mm Implants | 2019 |
| † | K080396 | Osseospeed Narrow | 2008 |
| † | K120414 | Osseospeed Plus | 2012 |
| † | K011394 | Lava Frame, Lava Frame Shade, Lava Ceram | 2001 |
| † | K130436 | Multilink Hybrid Abutment Cement | 2013 |
| † | K150704 | PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 8 companies; a new generation was cleared every 11 months on median.
- 43 of the 321 ancestors have a recall of any class.
- 1 other device also cites its predicate K230317.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Elos Accurate Hybrid Base The Elos Accurate® Hybrid Base TM is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base TM 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 TM is compatible with the…
Read the full statement (277 words)
Elos Accurate Hybrid Base
The Elos Accurate® Hybrid Base TM is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base TM 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 TM is compatible with the implant systems listed in table 1:
The zirconia superstructures for use with the Elos Accurate® Hybrid Base TM are either intended to be sent and manufactured at a 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.
Elos Accurate Customized Abutment
The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw.
The Elos Accurate® Customized Abutment is compatible with the implant systems listed in table 1:
All digitally designed CAD/CAM customizations for the Elos Accurate® Customized Abutments are either intended to be sent and manufactured at a 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, 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/K241722 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241722: Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241722
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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