510(k) · Cleared
ClearedCustomized Abutment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arum Dentistry Co., Ltd. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Apr 28, 2023 as substantially equivalent to K193425 (Arum Dentistry Co., Ltd., 2020) after a 144-day review. Its family tree reaches back 17 generations to 1990. 3 later devices descend from it.
- Decided
- Apr 28, 2023
- Review
- 144 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K894844 (1990). 174 ancestors in all, the oldest K871863 (1987). 3 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 backK193425 Pre-Milled BlankArum Dentistry Co., Ltd. · 2020
- This deviceK223634 Customized AbutmentArum Dentistry Co., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK234112 Customized AbutmentArum Dentistry Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK242768 Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK242245 Customized AbutmentArum Dentistry Co., Ltd. · 2024
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 backK193425 Pre-Milled BlankArum Dentistry Co., Ltd. · 2020
- This deviceK223634 Customized AbutmentArum Dentistry Co., Ltd. · 2023
Most influential descendants
Showing 3 of 3 · See allView 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 | K193425 | Pre-Milled Blank | Arum Dentistry Co., Ltd. | 2020 | — |
| 0 (this device) | K223634 | Customized Abutment | Arum Dentistry Co., Ltd. | 2023 | — |
| +1 | K234112 | Customized Abutment | Arum Dentistry Co., Ltd. | 2024 | — |
| +2 | K242768 | Customized Abutment and Screw | Chengdu Besmile Medical Technology Co., Ltd. | 2025 | — |
| +1 | K242245 | Customized Abutment | Arum Dentistry Co., Ltd. | 2024 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 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.
What descends from it? (3)
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 33 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 18 of the 174 ancestors have a recall of any class.
- Of its descendants, K234112 (Arum Dentistry Co., Ltd., 2024) has gone furthest, with 1 descendant 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. 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?
ARUM Dentistry’s Customized Abutments are intended for attachment to dental implants in order to provide support for customized prosthetic restorations. Customized Abutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations. The Customized Abutment will be attached to a dental implant using the included ARUM Dentistry prosthetic screw. Customized Abutments are compatible with the implant systems…
Read the full statement (105 words)
ARUM Dentistry’s Customized Abutments are intended for attachment to dental implants in order to provide support for customized prosthetic restorations. Customized Abutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations. The Customized Abutment will be attached to a dental implant using the included ARUM Dentistry prosthetic screw.
Customized Abutments are compatible with the implant systems listed in the Compatibility Table:
Implant Platform Restorative Platform
compatibility diameter (mm)
NB1SAlmplant | 54 4 4550 55,60,65 | 38 4.0, 4.15, 425, 45,50
System
Implant Body diameter (mm)
All digitally-designed Customized Abutments are intended to be sent to an ARUM Dentistry-validated milling center for manufacture.
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/K223634 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223634: 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/K223634
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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