510(k) · Cleared
ClearedTI-Base Abutment, 1 Connect Abutment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nt-Trading GmbH and CO KG · NHA Abutment, Implant, Dental, Endosseous
Cleared on Feb 17, 2012 as substantially equivalent to K093483 (Astra Tech, Inc., 2009) and 4 other predicates after a 224-day review. Its family tree reaches back 10 generations to 1990. 64 later devices descend from it.
- Decided
- Feb 17, 2012
- Review
- 224 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 10 generations to K894595 (1990). 43 ancestors in all, the oldest K894844 (1990). 64 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations between
- 3 generations backK062749 SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic…Nobel Biocare AB · 2006
- 2 generations backK072129 Nobelactive Zirconia AbutmentNobel Biocare AB · 2008
- 1 generation backK093483 Atlantis Abutment for Nobel Biocare Active Implant, Atlantis Gemini…Astra Tech, Inc. · 2009
- This deviceK111935 TI-Base Abutment, 1 Connect AbutmentNt-Trading GmbH and CO KG · 2012
- Descendant · cites it directly · 35 of its ownK132219 Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase…Straumann USA, LLC · 2014
- Descendant · 2 generations on · 30 of its ownK142890 Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN…Straumann USA, LLC · 2015
- Descendant · cites it directly · 29 of its ownK122295 Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L. · 2013
- Descendant · 2 generations on · 26 of its ownK151621 BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc. · 2016
- Descendant · 3 generations on · 22 of its ownK183518 Preat AbutmentsPreat Corporation · 2019 · Recalled
Show all 10 generations
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 9 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 8 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 7 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 6 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 5 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 4 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 3 generations backK062749 SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic…Nobel Biocare AB · 2006
- 2 generations backK072129 Nobelactive Zirconia AbutmentNobel Biocare AB · 2008
- 1 generation backK093483 Atlantis Abutment for Nobel Biocare Active Implant, Atlantis Gemini…Astra Tech, Inc. · 2009
- This deviceK111935 TI-Base Abutment, 1 Connect AbutmentNt-Trading GmbH and CO KG · 2012
Showing 5 of 64 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 64 · See all- K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC · 2014 · cites it directly35descendants
- K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC · 2015 · 2 generations on30descendants
- K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L. · 2013 · cites it directly29descendants
- K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc. · 2016 · 2 generations on26descendants
- K183518Preat AbutmentsPreat Corporation · 2019 · 3 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −9 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −8 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −7 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −6 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −5 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −4 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −3 | K062749 | SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP… | Nobel Biocare AB | 2006 | — |
| −2 | K072129 | Nobelactive Zirconia Abutment | Nobel Biocare AB | 2008 | — |
| −1 | K093483 | Atlantis Abutment for Nobel Biocare Active Implant, Atlantis Gemini Abutment… | Astra Tech, Inc. | 2009 | — |
| 0 (this device) | K111935 | TI-Base Abutment, 1 Connect Abutment | Nt-Trading GmbH and CO KG | 2012 | — |
| +1 | K132219 | Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM)… | Straumann USA, LLC | 2014 | — |
| +2 | K142890 | Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann… | Straumann USA, LLC | 2015 | — |
| +1 | K122295 | Core 3D Abutment System for Digital Prosthetic Solutions | Core 3D Protech, S.L. | 2013 | — |
| +2 | K151621 | BioHorizons CAD/CAM Abutments | BioHorizons Implant Systems, Inc. | 2016 | — |
| +3 | K183518 | Preat Abutments | Preat Corporation | 2019 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 6 | 0 |
| 2018 | 6 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 9 | 0 |
| 2022 | 6 | 0 |
| 2023 | 6 | 0 |
| 2024 | 5 | 0 |
| 2025 | 10 | 0 |
| 2026 | 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? (7)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K000152 | FDA’s K000152 is Kippmed I.V. Manifold Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2000 |
| Kept off the family tree | K083871 | FDA’s K083871 is Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann Bone Level… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2009 |
| * | K093483 | Atlantis Abutment for Nobel Biocare Active Implant, Atlantis Gemini Abutment, Gemini +…Summary page 1…NHA PeiaeDevices: (K00I52) Sirona Dental Systems Sirona Dental CAD/CAM System, (K83871) PredcateAtlantiSTM Straumann Bone Level Abutment, (K093483) Atlantisw Abutment for Nobel Active Implant, (K072642) Biomet 31Dental Abutments And Restorative… | 2009 |
| * | K072642 | Biomet 3I Dental Abutments and Restorative ComponentsSummary page 1…a Dental CAD/CAM System, (K83871) PredcateAtlantiSTM Straumann Bone Level Abutment, (K093483) Atlantisw Abutment for Nobel Active Implant, (K072642) Biomet 31Dental Abutments And Restorative Components, (K990342) synOcta® Prosthetics, (K080239) P.004 Abut… | 2007 |
| * | K990342 | Synocta ProstheticsSummary page 1…ment, (K093483) Atlantisw Abutment for Nobel Active Implant, (K072642) Biomet 31Dental Abutments And Restorative Components, (K990342) synOcta® Prosthetics, (K080239) P.004 Abutments, (K072570) NobelActive M MuIti Unit Abutment Devi… | 1999 |
| * | K080239 | P.004 Abutments, P.004 Temporary Copings, P.004 Protective Caps, P.004 Permanent CopingsSummary page 1…nt for Nobel Active Implant, (K072642) Biomet 31Dental Abutments And Restorative Components, (K990342) synOcta® Prosthetics, (K080239) P.004 Abutments, (K072570) NobelActive M MuIti Unit Abutment Device Description and The Ti-B… | 2008 |
| * | K072570 | Nobelactive Multi Unit AbutmentSummary page 1…642) Biomet 31Dental Abutments And Restorative Components, (K990342) synOcta® Prosthetics, (K080239) P.004 Abutments, (K072570) NobelActive M MuIti Unit Abutment Device Description and The Ti-Base Abutment is a premanufactured prosthetic component s… | 2007 |
What descends from it? (64)
See all 642 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 22 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 7 of the 43 ancestors have a recall of any class.
- Of its descendants, K132219 (Straumann USA, LLC, 2014) has gone furthest, with 35 descendants of its own.
- 1 other device also cites its predicate K093483.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Ti-Base for individual Zirconium Abutments: The devices covered by this submission are abutments which are placed into a dental implant to provide support for a prosthetic restoration. The Ti-Base for individual Zirconium Abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be…
Read the full statement (218 words)
Ti-Base for individual Zirconium Abutments: The devices covered by this submission are abutments which are placed into a dental implant to provide support for a prosthetic restoration.
The Ti-Base for individual Zirconium Abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
The Ti-Base abutments are indicated for use with the following implant systems:
* Nobel Biocare® Replace Select®
* Nobel Biocare NobelActiveTM
* Biomet 3i® Osseotite®
* Biomet 3i® Osseotite® Certain®
* Nobel Biocare Branemark®
* Straumann® synOcta®
* Straumann® Bone Level®
* Zimmer® Tapered Screw-vent®
* Astra Tech OsseoSpeed®
* Dentsply-Friadent® Frialit®
2-CONnect Abutment for Bridges and Bars: 2-CONnect Abutment for Bridges and Bars is indicated for use to provide support for prosthetic restorations such as bars and bridges. The 2-CONnect abutments can be used in multiple tooth restorations. The 2-CONnect abutment can be used together with cemented bridges and bar constructions for functional and aesthetical reconstruction.
The 2-CONnect abutments are indicated for use with the following implant systems:
* Nobel Biocare® Replace Select®
* Straumann® synOcta®
* Straumann® BoneLevel®
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/K111935 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111935: TI-Base Abutment, 1 Connect Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111935
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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