510(k) · Cleared
ClearedDIO CAD/CAM Abutment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dio Corporation · NHA Abutment, Implant, Dental, Endosseous
Cleared on Dec 21, 2018 as substantially equivalent to K150203 (Medentika GmbH, 2015) and 2 other predicates after a 246-day review. Its family tree reaches back 14 generations to 1990. 7 later devices descend from it.
- Decided
- Dec 21, 2018
- Review
- 246 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K894844 (1990). 217 ancestors in all, the oldest K781060 (1978). 7 later devices descend from it, 5 citing it directly.
- Root · 14 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 10 generations between
- 3 generations backK101465 Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010
- 2 generations backK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- 1 generation backK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
- This deviceK181037 DIO CAD/CAM AbutmentDio Corporation · 2018
- Descendant · cites it directly · 1 of its ownK222913 s-Clean Link AbutmentDentis Co., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK210362 s-Clean Pre-Milled AbutmentDentis Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK242703 LW Pre-milled AbutmentOssvis Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK232170 Ti Link AbutmentIzenimplant Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK230523 s-Clean Link Abutment NarrowDentis Co., Ltd. · 2023
Show all 14 generations
- Root · 14 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 13 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 12 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 11 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 10 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 9 generations backK052272 Straumann Computer Aided Restoration ServiceStraumann USA · 2006
- 8 generations backK061277 Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic…Straumann USA · 2007
- 7 generations backK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
- 6 generations backK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- 5 generations backK082545 Straumann NN Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008
- 4 generations backK093113 Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG · 2009
- 3 generations backK101465 Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010
- 2 generations backK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- 1 generation backK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
- This deviceK181037 DIO CAD/CAM AbutmentDio Corporation · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K222913s-Clean Link AbutmentDentis Co., Ltd. · 2023 · cites it directly1descendant
- K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd. · 2021 · cites it directly1descendant
- K242703LW Pre-milled AbutmentOssvis Co., Ltd. · 2024 · 2 generations on0descendants
- K232170Ti Link AbutmentIzenimplant Co., Ltd. · 2024 · cites it directly0descendants
- K230523s-Clean Link Abutment NarrowDentis Co., Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −13 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −12 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −11 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −10 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −9 | K052272 | Straumann Computer Aided Restoration Service | Straumann USA | 2006 | — |
| −8 | K061277 | Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping | Straumann USA | 2007 | — |
| −7 | K072151 | P.004 RC Cares Titanium and Ceramic Abutments | Straumann USA | 2007 | 1 |
| −6 | K081005 | P.004 NC Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | 1 |
| −5 | K082545 | Straumann NN Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | — |
| −4 | K093113 | Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam Abutment | Institut Straumann AG | 2009 | — |
| −3 | K101465 | Straumann Cares Bridge; Straumann Cares Dolder Bar | Institut Straumann AG | 2010 | — |
| −2 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
| −1 | K150203 | Medentika CAD/CAM Abutments | Medentika GmbH | 2015 | — |
| 0 (this device) | K181037 | DIO CAD/CAM Abutment | Dio Corporation | 2018 | — |
| +1 | K222913 | s-Clean Link Abutment | Dentis Co., Ltd. | 2023 | — |
| +1 | K210362 | s-Clean Pre-Milled Abutment | Dentis Co., Ltd. | 2021 | — |
| +2 | K242703 | LW Pre-milled Abutment | Ossvis Co., Ltd. | 2024 | — |
| +1 | K232170 | Ti Link Abutment | Izenimplant Co., Ltd. | 2024 | — |
| +2 | K230523 | s-Clean Link Abutment Narrow | Dentis Co., Ltd. | 2023 | — |
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 | 6 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 12 | 0 |
| 1994 | 11 | 0 |
| 1995 | 11 | 0 |
| 1996 | 15 | 0 |
| 1997 | 6 | 0 |
| 1998 | 8 | 0 |
| 1999 | 8 | 0 |
| 2000 | 6 | 0 |
| 2001 | 10 | 0 |
| 2002 | 14 | 0 |
| 2003 | 11 | 0 |
| 2004 | 10 | 0 |
| 2005 | 11 | 0 |
| 2006 | 14 | 0 |
| 2007 | 14 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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? (3)
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 |
|---|---|---|---|
| * | K150203 | Medentika CAD/CAM AbutmentsSummary page 4…ed: 12/21/2018 Predicate Devices: The subject device is substantially equivalent to the following predicate device: Primary Predicate • Medentika CAD/CAM Abutment (K150203) Reference Devices • Sirona Dental CAD/CAM System (K111421) • Zimmer® patient Specific Abutment, Internal Hex, Titanium(… | 2015 |
| * | K143505 | Zimmer Patient-Specific Abutment, Internal Hex, TitaniumSummary page 4…• Medentika CAD/CAM Abutment (K150203) Reference Devices • Sirona Dental CAD/CAM System (K111421) • Zimmer® patient Specific Abutment, Internal Hex, Titanium(K143505) • Encode Patient Specific Abutment for Straumann Bone Level Connection(K112730) • UF(II) Narrow Implant System (K161987)… | 2015 |
| * | K112730 | Abutment for Competitive Implant Straumann Bone Level ConnectionSummary page 4…/CAM System (K111421) • Zimmer® patient Specific Abutment, Internal Hex, Titanium(K143505) • Encode Patient Specific Abutment for Straumann Bone Level Connection(K112730) • UF(II) Narrow Implant System (K161987) • UF Sub Merged Implant System (K122519) • UF(II) Implant System (K170608)… | 2012 |
| † | K111421 | Sirona Dental Cad/Cam System | 2012 |
| † | K161987 | UF (II) Narrow Implant System - Fixture, UF (II) Narrow Implant System - Suprastructure | 2017 |
| † | K122519 | Dio UF Hsa Internal Sub-Merged Implant System | 2013 |
| † | K170608 | UF (II) Implant System | 2018 |
| † | K073173 | Self-Adhesive Resin Cement | 2008 |
| † | K131117 | Zirmon Series | 2013 |
What descends from it? (7)
5 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 28 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 25 of the 217 ancestors have a recall of any class.
- Of its descendants, K222913 (Dentis Co., Ltd., 2023) has gone furthest, with 1 descendant of its own.
- 13 other devices also cite its predicate K150203.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
DIO CAD/CAM Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. Implant System Compatibility Implant Diameter (mm) Platform Diameter (mm) UF(II) Narrow Implant System 3.0/3.3 3.0/3.3 UF Sub merged Implant System 3.8/4.0/4.5/5.0/5.5/6.0/6.5/7.0 3.8/4.0/4.5/5.0/5.5/6.0/6.5/7.0 UF(II) Implant System 3.8/4.0/4.5/5.0/5.5…
Read the full statement (96 words)
DIO CAD/CAM Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
Implant System Compatibility Implant Diameter (mm) Platform Diameter (mm)
UF(II) Narrow Implant System 3.0/3.3 3.0/3.3
UF Sub merged Implant System 3.8/4.0/4.5/5.0/5.5/6.0/6.5/7.0 3.8/4.0/4.5/5.0/5.5/6.0/6.5/7.0
UF(II) Implant System 3.8/4.0/4.5/5.0/5.5 3.8/4.0/4.5/5.0/5.5
Patient specific abutment is intended for use with the UF Implant Systems provided in the chart. All digitally designed abutments for use with DIO CAD/CAM Abutments are intended to be manufactured at a DIO Corporation validated milling center.
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/K181037 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181037: DIO CAD/CAM Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181037
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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