510(k) · Cleared
ClearedElos 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 Nov 30, 2022 as substantially equivalent to K190299 (Elos Medtech Pinol A/S, 2019) and 3 other predicates after a 142-day review. Its family tree reaches back 17 generations to 1990. 4 later devices descend from it.
- Decided
- Nov 30, 2022
- Review
- 142 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 17 generations to K894844 (1990). 175 ancestors in all, the oldest K871863 (1987). 4 later devices descend from it, 2 citing it directly.
- Root · 17 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 13 generations between
- 3 generations backK171799 Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S · 2018
- 2 generations backK190299 Elos Accurate® Customized AbutmentElos Medtech Pinol A/S · 2019
- 1 generation backK192457 Elos Accurate Customized AbutmentElos Medtech Pinol A/S · 2020
- This deviceK222044 Elos Accurate Customized AbutmentElos Medtech Pinol A/S · 2022
- Descendant · cites it directly · 1 of its ownK231307 Elos Accurate Customized AbutmentElos Medtech Pinol A/S · 2023
- Descendant · cites it directly · 1 of its ownK223677 Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB · 2023
- Descendant · 2 generations on · 0 of its ownK250178 Adin Customized AbutmentsAdin Dental Implant Systems, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK243521 Conical Ti Base abutmentsBioHorizons Implant Systems, Inc. · 2025
Show all 17 generations
- Root · 17 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 16 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 15 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 14 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 13 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 12 generations backK052272 Straumann Computer Aided Restoration ServiceStraumann USA · 2006
- 11 generations backK061277 Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic…Straumann USA · 2007
- 10 generations backK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
- 9 generations backK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- 8 generations backK082545 Straumann NN Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008
- 7 generations backK093113 Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG · 2009
- 6 generations backK101465 Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010
- 5 generations backK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- 4 generations backK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
- 3 generations backK171799 Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S · 2018
- 2 generations backK190299 Elos Accurate® Customized AbutmentElos Medtech Pinol A/S · 2019
- 1 generation backK192457 Elos Accurate Customized AbutmentElos Medtech Pinol A/S · 2020
- This deviceK222044 Elos Accurate Customized AbutmentElos Medtech Pinol A/S · 2022
Most influential descendants
Showing 4 of 4 · See all- K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S · 2023 · cites it directly1descendant
- K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB · 2023 · cites it directly1descendant
- K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd. · 2025 · 2 generations on0descendants
- K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −16 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −15 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −14 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −13 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −12 | K052272 | Straumann Computer Aided Restoration Service | Straumann USA | 2006 | — |
| −11 | K061277 | Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping | Straumann USA | 2007 | — |
| −10 | K072151 | P.004 RC Cares Titanium and Ceramic Abutments | Straumann USA | 2007 | 1 |
| −9 | K081005 | P.004 NC Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | 1 |
| −8 | K082545 | Straumann NN Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | — |
| −7 | K093113 | Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam Abutment | Institut Straumann AG | 2009 | — |
| −6 | K101465 | Straumann Cares Bridge; Straumann Cares Dolder Bar | Institut Straumann AG | 2010 | — |
| −5 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
| −4 | K150203 | Medentika CAD/CAM Abutments | Medentika GmbH | 2015 | — |
| −3 | K171799 | Elos Accurate Customized Abutment, Elos Prosthetic Screw | Elos Medtech Pinol A/S | 2018 | — |
| −2 | K190299 | Elos Accurate® Customized Abutment | Elos Medtech Pinol A/S | 2019 | — |
| −1 | K192457 | Elos Accurate Customized Abutment | Elos Medtech Pinol A/S | 2020 | — |
| 0 (this device) | K222044 | Elos Accurate Customized Abutment | Elos Medtech Pinol A/S | 2022 | — |
| +1 | K231307 | Elos Accurate Customized Abutment | Elos Medtech Pinol A/S | 2023 | — |
| +1 | K223677 | Titanium Abutment Blank Nobel Biocare N1 TCC | Nobel Biocare AB | 2023 | — |
| +2 | K250178 | Adin Customized Abutments | Adin Dental Implant Systems, Ltd. | 2025 | — |
| +2 | K243521 | Conical Ti Base abutments | BioHorizons Implant Systems, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 12 | 0 |
| 1994 | 11 | 0 |
| 1995 | 8 | 0 |
| 1996 | 13 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 7 | 0 |
| 2000 | 6 | 0 |
| 2001 | 9 | 0 |
| 2002 | 12 | 0 |
| 2003 | 8 | 0 |
| 2004 | 9 | 0 |
| 2005 | 8 | 0 |
| 2006 | 13 | 0 |
| 2007 | 11 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K190299 | Elos Accurate® Customized AbutmentSummary page 5…for Use of the subject devices are substantially equivalent to the predicate devices noted below. Primary Predicate Device: • K190299 I SE 06/26/2019 - Elos Accurate® Customized Abutment • K171799 / SE 01/15/2018 - Elos Accurate® Customized Abutment… | 2019 |
| * | K171799 | Elos Accurate Customized Abutment, Elos Prosthetic ScrewSummary page 5…the predicate devices noted below. Primary Predicate Device: • K190299 I SE 06/26/2019 - Elos Accurate® Customized Abutment • K171799 / SE 01/15/2018 - Elos Accurate® Customized Abutment • K192457 / SE 01/02/2020 - Elos Accurate® Customized Abutment… | 2018 |
| * | K192457 | Elos Accurate Customized AbutmentSummary page 5…• K190299 I SE 06/26/2019 - Elos Accurate® Customized Abutment • K171799 / SE 01/15/2018 - Elos Accurate® Customized Abutment • K192457 / SE 01/02/2020 - Elos Accurate® Customized Abutment • K191890 / SE 02/06/2020 - Elos Accurate® Customized Abutment… | 2020 |
| * | K191890 | Elos Accurate Customized AbutmentSummary page 5…• K171799 / SE 01/15/2018 - Elos Accurate® Customized Abutment • K192457 / SE 01/02/2020 - Elos Accurate® Customized Abutment • K191890 / SE 02/06/2020 - Elos Accurate® Customized Abutment Reference Devices: • K201860 / SE 02/19/2021 -… | 2020 |
| † | K201860 | Elos Accurate Hybrid Base | 2021 |
| † | K151455 | 3Shape Abutment Designer Software | 2016 |
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 32 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 18 of the 175 ancestors have a recall of any class.
- Of its descendants, K231307 (Elos Medtech Pinol A/S, 2023) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K190299.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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® 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 Abutments are compatible with the implant systems listed in Table 1: Table 1. Implant Platform compatibility — Platform diameter [mm] — Implant…
Read the full statement (283 words)
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 Abutments are 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 3.5/4.0 — 3.5 & 4 — 3.5 & 4
Astra Tech 4.5/5.0 — 4.5 & 5 — 4.5 & 5
Astra Tech EV 3.6 — 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
All digitally designed CAD/CAM customizations for the Elos Accurate® Customized Abutments 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, milling machine and associated tooling and accessories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222044 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222044: 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/K222044
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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