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 Nov 25, 2024 as substantially equivalent to K223634 (Arum Dentistry Co., Ltd., 2023) after a 117-day review. Its family tree reaches back 18 generations to 1990.
- Decided
- Nov 25, 2024
- Review
- 117 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 18 generations to K894844 (1990). 175 ancestors in all, the oldest K871863 (1987). No later device cites it as a predicate yet.
- Root · 18 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 14 generations between
- 3 generations backK190299 Elos Accurate® Customized AbutmentElos Medtech Pinol A/S · 2019
- 2 generations backK193425 Pre-Milled BlankArum Dentistry Co., Ltd. · 2020
- 1 generation backK223634 Customized AbutmentArum Dentistry Co., Ltd. · 2023
- This deviceK242245 Customized AbutmentArum Dentistry Co., Ltd. · 2024
Show all 18 generations
- Root · 18 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 17 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 16 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 15 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 14 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 13 generations backK052272 Straumann Computer Aided Restoration ServiceStraumann USA · 2006
- 12 generations backK061277 Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic…Straumann USA · 2007
- 11 generations backK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
- 10 generations backK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- 9 generations backK082545 Straumann NN Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008
- 8 generations backK093113 Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG · 2009
- 7 generations backK101465 Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010
- 6 generations backK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- 5 generations backK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
- 4 generations backK171799 Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S · 2018
- 3 generations backK190299 Elos Accurate® Customized AbutmentElos Medtech Pinol A/S · 2019
- 2 generations backK193425 Pre-Milled BlankArum Dentistry Co., Ltd. · 2020
- 1 generation backK223634 Customized AbutmentArum Dentistry Co., Ltd. · 2023
- This deviceK242245 Customized AbutmentArum Dentistry Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −17 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −16 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −15 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −14 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −13 | K052272 | Straumann Computer Aided Restoration Service | Straumann USA | 2006 | — |
| −12 | K061277 | Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping | Straumann USA | 2007 | — |
| −11 | K072151 | P.004 RC Cares Titanium and Ceramic Abutments | Straumann USA | 2007 | 1 |
| −10 | K081005 | P.004 NC Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | 1 |
| −9 | K082545 | Straumann NN Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | — |
| −8 | K093113 | Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam Abutment | Institut Straumann AG | 2009 | — |
| −7 | K101465 | Straumann Cares Bridge; Straumann Cares Dolder Bar | Institut Straumann AG | 2010 | — |
| −6 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
| −5 | K150203 | Medentika CAD/CAM Abutments | Medentika GmbH | 2015 | — |
| −4 | K171799 | Elos Accurate Customized Abutment, Elos Prosthetic Screw | Elos Medtech Pinol A/S | 2018 | — |
| −3 | K190299 | Elos Accurate® Customized Abutment | Elos Medtech Pinol A/S | 2019 | — |
| −2 | K193425 | Pre-Milled Blank | Arum Dentistry Co., Ltd. | 2020 | — |
| −1 | K223634 | Customized Abutment | Arum Dentistry Co., Ltd. | 2023 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K223634 | Customized AbutmentSummary page 5…lass II Date Prepared: 11/25/2024 Predicate Devices: The subject device is substantially equivalent to the following predicate devices: Primary Predicate • K223634, Customized Abutment by ARUM DENTISTRY Co., Ltd. Reference Device • K163194, Neodent Implant System - GM Line manufactured… | 2023 |
| † | K163194 | Neodent Implant System - GM Line | 2017 |
| † | K180536 | Neodent Implant System – GM Line | 2018 |
| † | K071638 | Biohorizons Tapered Internal Implant System | 2007 |
| † | K091239 | Astra Tech Implant System | 2009 |
| † | K063341 | 3I Osseotite Certain Dental Implants | 2007 |
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 34 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 18 of the 175 ancestors have a recall of any class.
- 1 other device also cites its predicate K223634.
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?
The Customized Abutments are intended use 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 abutment screw. Patient-Specific Abutment is compatible with following Implant System: 1. Neodent Implant…
Read the full statement (157 words)
The Customized Abutments are intended use 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 abutment screw.
Patient-Specific Abutment is compatible with following Implant System:
1. Neodent Implant System -GM Line
/ Implant Diameter (mm): 3.5, 3.75, 4.0, 4.3, 5.0, 6.0/ Restorative Platform Diameter: 3.0
2. BioHorizons Tapered Internal Implant System
/ Implant Diameter (mm): 3.8, 4.6, 5.8/ Restorative Platform Diameter: 3.5, 4.5, 5.7
3. Astra Tech Implant System
/ Implant Diameter (mm): 3.5, 4.0, 4.5, 5.0/ Restorative Platform Diameter: 3.5, 4.0, 4.5, 5.0
4. 3i OSSEOTITE® Certain® Dental Implants
/ Implant Diameter (mm): 4.1, 5.0, 6.0/ Restorative Platform Diameter: 4.1, 5.0, 6.0
All digitally designed abutments for use with Customized Abutment are intended to be manufactured at an ARUM DENTISTRY validated milling center.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242245 · printed Nov 4, 2026
Cite this page
510(k) Report. “K242245: Customized Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K242245
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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