510(k) · Cleared
ClearedMedentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medentika GmbH · NHA Abutment, Implant, Dental, Endosseous
Cleared on Apr 15, 2024 as substantially equivalent to K142167 (Medentika GmbH, 2015) after a 560-day review. Its family tree reaches back 13 generations to 1990. 3 later devices descend from it.
- Decided
- Apr 15, 2024
- Review
- 560 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K894595 (1990). 211 ancestors in all, the oldest K781060 (1978). 3 later devices descend from it, 3 citing it directly.
- Root · 13 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 9 generations between
- 3 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- 2 generations backK120414 Osseospeed PlusAstra Tech AB · 2012
- 1 generation backK142167 Medentika Abutment SystemMedentika GmbH · 2015
- This deviceK223113 Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika…Medentika GmbH · 2024
- Descendant · cites it directly · 0 of its ownK260460 Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG · 2026
- Descendant · cites it directly · 0 of its ownK253341 Custom Abutments ASMedentika GmbH · 2025
- Descendant · cites it directly · 0 of its ownK242542 Medentika CAD/CAM AbutmentsMedentika GmbH · 2025
Show all 13 generations
- Root · 13 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 12 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 11 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 10 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 9 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 8 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 7 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 6 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 5 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- 4 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- 3 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- 2 generations backK120414 Osseospeed PlusAstra Tech AB · 2012
- 1 generation backK142167 Medentika Abutment SystemMedentika GmbH · 2015
- This deviceK223113 Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika…Medentika GmbH · 2024
Most influential descendants
Showing 3 of 3 · See all- K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG · 2026 · cites it directly0descendants
- K253341Custom Abutments ASMedentika GmbH · 2025 · cites it directly0descendants
- K242542Medentika CAD/CAM AbutmentsMedentika GmbH · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −12 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −11 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −10 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −9 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −8 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −7 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −6 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −5 | K101732 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −4 | K111287 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −3 | K112138 | Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant | Astra Tech, Inc. | 2011 | — |
| −2 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| −1 | K142167 | Medentika Abutment System | Medentika GmbH | 2015 | — |
| 0 (this device) | K223113 | Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM… | Medentika GmbH | 2024 | — |
| +1 | K260460 | Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue | Institut Straumann AG | 2026 | — |
| +1 | K253341 | Custom Abutments AS | Medentika GmbH | 2025 | — |
| +1 | K242542 | Medentika CAD/CAM Abutments | Medentika GmbH | 2025 | — |
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 | 10 | 0 |
| 1995 | 12 | 0 |
| 1996 | 15 | 0 |
| 1997 | 6 | 0 |
| 1998 | 8 | 0 |
| 1999 | 8 | 0 |
| 2000 | 6 | 0 |
| 2001 | 10 | 0 |
| 2002 | 13 | 0 |
| 2003 | 12 | 0 |
| 2004 | 8 | 0 |
| 2005 | 5 | 0 |
| 2006 | 8 | 0 |
| 2007 | 13 | 0 |
| 2008 | 6 | 0 |
| 2009 | 7 | 0 |
| 2010 | 6 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 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? (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 |
|---|---|---|---|
| * | K142167 | Medentika Abutment SystemSummary page 10…510(k) Summary Product Code(s): NHA Classification Panel: Dental Predicate and Reference Device(s) Primary Predicate: • K142167 – Medentika Abutment System Reference Devices for Abutments: • K150203 – Medentika CAD/CAM Abutments • K170838 –… | 2015 |
| † | K150203 | Medentika CAD/CAM Abutments | 2015 |
| † | K170838 | Medentika CAD/CAM TiBases | 2017 |
| † | K191123 | Multi-unit Abutments | 2020 |
| † | K130999 | Osseospeed Profile EV | 2013 |
| † | K120414 | Osseospeed Plus | 2012 |
| † | K101732 | Astra Tech Implant System | 2011 |
| † | K121995 | TS Fixture System | 2012 |
| † | K161604 | OSSTEM Implant System | 2016 |
| † | K140934 | Hiossen Implant System | 2014 |
| † | K142260 | NobelActive | 2015 |
| † | K020646 | Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162, 50102… | 2002 |
| † | K061410 | Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant… | 2006 |
| † | K073142 | Nobelreplace Hexagonal Implant | 2008 |
| † | K061804 | Zerion Alpha, ; Zerion Beta | 2006 |
| † | K180564 | Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases | 2019 |
What descends from it? (3)
3 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 34 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 26 of the 211 ancestors have a recall of any class.
- Of its descendants, K260460 (Institut Straumann AG, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K142167.
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?
Medentika abutments are 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. Medentika abutments for the Dentsply Sirona Astra Tech OsseoSpeed EV 3.0mm and TX 3.0mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only. Medentika TiBase CAD/CAM Abutments are intended for use with dental implants as a…
Read the full statement (281 words)
Medentika abutments are 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.
Medentika abutments for the Dentsply Sirona Astra Tech OsseoSpeed EV 3.0mm and TX 3.0mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
Medentika TiBase CAD/CAM Abutments are 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. Medentika TiBase is intended for use with the Straumann® CARES® System. All digitally designed copings and/or crowns are intended to be sent to Straumann for manufacture at a validated milling center.
Medentika abutments for the Nobel Biocare Nobel Active®* 3.0mm, Dentsply Sirona Astra Tech OsseoSpeed EV®* 3.0mm and TX®* 3.0mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
Medentika PreFace CAD/CAM Abutments are 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.
Medentika Preface is intended for use with the Straumann® CARES® System. All digitally designed abutments for use with Medentika CAD/CAM Abutments are intended to be manufactured at a Straumann® CARES® validated milling center. The final patient matched form is a MedentiCAD abutment.
Medentika abutments for the Dentsply Sirona Astra Tech OsseoSpeed EV 3.0mm and TX 3.0mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
Multi-unit abutments are indicated for use with dental implants as a support for multi-unit screw retained bridges and bars in the maxilla or mandible of a partially or fully edentulous patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223113 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223113: Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223113
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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