510(k) · Cleared
ClearedDD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dental Direkt GmbH · NHA Abutment, Implant, Dental, Endosseous
Cleared on Apr 25, 2023 as substantially equivalent to K191111 (Dental Direkt GmbH, 2023) after an 89-day review. Its family tree reaches back 17 generations to 1990.
- Decided
- Apr 25, 2023
- Review
- 89 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K894844 (1990). 263 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 17 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 13 generations between
- 3 generations backK170838 Medentika CAD/CAM TiBasesMedentika GmbH · 2017
- 2 generations backK180564 Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika…Medentika GmbH · 2019
- 1 generation backK191111 DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH · 2023
- This deviceK230218 DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH · 2023
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 backK170838 Medentika CAD/CAM TiBasesMedentika GmbH · 2017
- 2 generations backK180564 Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika…Medentika GmbH · 2019
- 1 generation backK191111 DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH · 2023
- This deviceK230218 DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH · 2023
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 | K170838 | Medentika CAD/CAM TiBases | Medentika GmbH | 2017 | — |
| −2 | K180564 | Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM… | Medentika GmbH | 2019 | — |
| −1 | K191111 | DD Solid Connect® CAD/CAM Abutments | Dental Direkt GmbH | 2023 | — |
| 0 (this device) | K230218 | DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) | Dental Direkt GmbH | 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 | 4 | 0 |
| 1993 | 12 | 0 |
| 1994 | 11 | 0 |
| 1995 | 13 | 0 |
| 1996 | 16 | 0 |
| 1997 | 6 | 0 |
| 1998 | 8 | 0 |
| 1999 | 8 | 0 |
| 2000 | 9 | 0 |
| 2001 | 12 | 0 |
| 2002 | 16 | 0 |
| 2003 | 12 | 0 |
| 2004 | 13 | 0 |
| 2005 | 11 | 0 |
| 2006 | 16 | 0 |
| 2007 | 18 | 0 |
| 2008 | 10 | 0 |
| 2009 | 9 | 0 |
| 2010 | 7 | 0 |
| 2011 | 8 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2015 | 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 30.7 · 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 |
|---|---|---|---|
| * | K191111 | DD Solid Connect® CAD/CAM AbutmentsSummary page 4…NHA Panel Dental Classification Class 2 Primary Predicate Device K191111 Dental Direkt GmbH - DD Solid Connect® CAD/CAM Abutments Indications for Use… | 2023 |
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 33 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 31 of the 263 ancestors have a recall of any class.
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?
DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) are used to support prosthetic restorations in combination with endosseous dental implants in the upper and/or lower jaw. DD Ti-Base 2CUT abutments, for the Altatech Camlog Screw-Line 3.3mm implant bodies, Dentsply Implants Astra Tech OsseoSpeed 3.5mm implant bodies, Dentsply Implants Xive 3.4mm implant bodies, Straumann Bone Level 3.3mm implant bodies, Zimmer Biomet 3i Certain 3.4mm…
Read the full statement (193 words)
DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) are used to support prosthetic restorations in combination with endosseous dental implants in the upper and/or lower jaw.
DD Ti-Base 2CUT abutments, for the Altatech Camlog Screw-Line 3.3mm implant bodies, Dentsply Implants Astra Tech OsseoSpeed 3.5mm implant bodies, Dentsply Implants Xive 3.4mm implant bodies, Straumann Bone Level 3.3mm implant bodies, Zimmer Biomet 3i Certain 3.4mm implant bodies and Zimmer Dental Tapered Screw-Vent 3.5mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
All digitally designed custom abutments for use with DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) are to be sent to a Dental Direkt validated milling center for manufacture.
Compatible Implant Systems:
- Altatech: Camlog (3.3, 3.8, 4.3, 5.0)
- Nobel Biocare: Nobel Active (3.5, 4.3/5.0)
- Nobel Biocare: Replace Select Tapered (3.5, 4.3, 5.0)
- Dentsply Implants: Xive (3.4, 3.8, 4.5, 5.5)
- Straumann: Bone Level (3.3, 4.1/4.8)
- Straumann: SynOcta (4.8, 6.5)
- Zimmer Dental: Tapered Screw-Vent (3.5, 4.5, 5.7)
- Dentsply Implants: Astra Tech OsseoSpeed (3.5/4.0, 4.5/5.0)
- Dentsply Implants: Astra EV (3.6, 4.2, 4.8, 5.4)
- Zimmer Biomet 3i: Certain (3.4, 4.1/5.0)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230218 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230218: DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230218
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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