510(k) · Cleared
ClearedMedentika Abutment System
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 Feb 20, 2015 as substantially equivalent to K020646 (Nobel Biocare Uas, Inc., 2002) and 17 other predicates after a 198-day review. Its family tree reaches back 12 generations to 1990. 7 later devices descend from it.
- Decided
- Feb 20, 2015
- Review
- 198 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 18
Its longest line of descent runs back 12 generations to K894595 (1990). 210 ancestors in all, the oldest K781060 (1978). 7 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations between
- 3 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- 2 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- 1 generation backK120414 Osseospeed PlusAstra Tech AB · 2012
- This deviceK142167 Medentika Abutment SystemMedentika GmbH · 2015
- Descendant · cites it directly · 3 of its ownK223113 Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika…Medentika GmbH · 2024
- Descendant · cites it directly · 2 of its ownK180564 Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika…Medentika GmbH · 2019
- Descendant · 2 generations on · 1 of its ownK191111 DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH · 2023
- Descendant · 2 generations on · 0 of its ownK260460 Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG · 2026
- Descendant · 2 generations on · 0 of its ownK253341 Custom Abutments ASMedentika GmbH · 2025
Show all 12 generations
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 11 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 10 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 9 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 8 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 7 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 6 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 5 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 4 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- 3 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- 2 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- 1 generation backK120414 Osseospeed PlusAstra Tech AB · 2012
- This deviceK142167 Medentika Abutment SystemMedentika GmbH · 2015
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH · 2024 · cites it directly3descendants
- K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH · 2019 · cites it directly2descendants
- K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH · 2023 · 2 generations on1descendant
- K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG · 2026 · 2 generations on0descendants
- K253341Custom Abutments ASMedentika GmbH · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −11 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −10 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −9 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −8 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −7 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −6 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −5 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −4 | K101732 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −3 | K111287 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −2 | K112138 | Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant | Astra Tech, Inc. | 2011 | — |
| −1 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| 0 (this device) | K142167 | Medentika Abutment System | Medentika GmbH | 2015 | — |
| +1 | K223113 | Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM… | Medentika GmbH | 2024 | — |
| +1 | K180564 | Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM… | Medentika GmbH | 2019 | — |
| +2 | K191111 | DD Solid Connect® CAD/CAM Abutments | Dental Direkt GmbH | 2023 | — |
| +2 | K260460 | Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue | Institut Straumann AG | 2026 | — |
| +2 | K253341 | Custom Abutments AS | 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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 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? (18)
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 |
|---|---|---|---|
| * | K020646 | Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162, 50102…Summary page 5…oriented toward the corner or lobe of the anti-rotational feature. The maximum angle for any abutment within the eleven systems is 21°. EQUIVALENCE TO MARKETED DEVICE K020646 Replace™ HA Coated Implant K071370 NobelActive Internal Connection Implant K063341 3i OSSEOTITE Certain® Dental Implants… | 2002 |
| * | K071370 | Nobelactive Internal Connection ImplantSummary page 5…the anti-rotational feature. The maximum angle for any abutment within the eleven systems is 21°. EQUIVALENCE TO MARKETED DEVICE K020646 Replace™ HA Coated Implant K071370 NobelActive Internal Connection Implant K063341 3i OSSEOTITE Certain® Dental Implants K063286 OSSEOTITE Dental Implants… | 2007 |
| * | K063341 | 3I Osseotite Certain Dental ImplantsSummary page 5…any abutment within the eleven systems is 21°. EQUIVALENCE TO MARKETED DEVICE K020646 Replace™ HA Coated Implant K071370 NobelActive Internal Connection Implant K063341 3i OSSEOTITE Certain® Dental Implants K063286 OSSEOTITE Dental Implants K022562 Various Brånemark System Implants – Imme… | 2007 |
| * | K063286 | Osseotite; Osseotite NT; XP; TG OsseotiteSummary page 5…EQUIVALENCE TO MARKETED DEVICE K020646 Replace™ HA Coated Implant K071370 NobelActive Internal Connection Implant K063341 3i OSSEOTITE Certain® Dental Implants K063286 OSSEOTITE Dental Implants K022562 Various Brånemark System Implants – Immediate Function Indication K062129 P.004 Implan… | 2007 |
| * | K022562 | Various Branemark System Implants-Immediate Function IndicationSummary page 5…46 Replace™ HA Coated Implant K071370 NobelActive Internal Connection Implant K063341 3i OSSEOTITE Certain® Dental Implants K063286 OSSEOTITE Dental Implants K022562 Various Brånemark System Implants – Immediate Function Indication K062129 P.004 Implants K130222 Straumann Dental Implan… | 2002 |
| * | K062129 | P.0004 ImplantsSummary page 5…mplant K063341 3i OSSEOTITE Certain® Dental Implants K063286 OSSEOTITE Dental Implants K022562 Various Brånemark System Implants – Immediate Function Indication K062129 P.004 Implants K130222 Straumann Dental Implant System SLActive and Roxoid Product Families K061410 Zimmer Dental Implan… | 2006 |
| * | K130222 | Straumann Dental Implant SystemSummary page 5…TITE Certain® Dental Implants K063286 OSSEOTITE Dental Implants K022562 Various Brånemark System Implants – Immediate Function Indication K062129 P.004 Implants K130222 Straumann Dental Implant System SLActive and Roxoid Product Families K061410 Zimmer Dental Implant System K101732 Astra… | 2013 |
| * | K061410 | Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant…Summary page 5…rious Brånemark System Implants – Immediate Function Indication K062129 P.004 Implants K130222 Straumann Dental Implant System SLActive and Roxoid Product Families K061410 Zimmer Dental Implant System K101732 Astra Tech Implant System K073075 FRIADENT Implant Systems K142167… | 2006 |
| * | K101732 | Astra Tech Implant SystemSummary page 5…ate Function Indication K062129 P.004 Implants K130222 Straumann Dental Implant System SLActive and Roxoid Product Families K061410 Zimmer Dental Implant System K101732 Astra Tech Implant System K073075 FRIADENT Implant Systems K142167… | 2011 |
| * | K073075 | Frialit Plus, Xive S Plus, Xive TG Plus, Ankylos Plus, Dental Implant SystemsSummary page 5…004 Implants K130222 Straumann Dental Implant System SLActive and Roxoid Product Families K061410 Zimmer Dental Implant System K101732 Astra Tech Implant System K073075 FRIADENT Implant Systems K142167 Medentika… | 2008 |
| * | K041509 | Ankylos Dental Implant SystemSummary page 6…Implant System K073075 FRIADENT Implant Systems K142167 Medentika Abutment System K041509 ANKYLOS® Dental Implant System K072570 NobelActive Multi-Unit Abutment K093643 Multi-Unit Abutments for Straumann and As… | 2004 |
| * | K072570 | Nobelactive Multi Unit AbutmentSummary page 6…Systems K142167 Medentika Abutment System K041509 ANKYLOS® Dental Implant System K072570 NobelActive Multi-Unit Abutment K093643 Multi-Unit Abutments for Straumann and Astra Tech Implant Systems K072878 Locato… | 2007 |
| * | K093643 | Multi- Unit Abutments for Straumann and Astra Tech Implant SystemsSummary page 6…Medentika Abutment System K041509 ANKYLOS® Dental Implant System K072570 NobelActive Multi-Unit Abutment K093643 Multi-Unit Abutments for Straumann and Astra Tech Implant Systems K072878 Locator Implant Anchor K092434 2.2 mm Angled M… | 2010 |
| * | K072878 | Modification to: Locator Implant AnchorSummary page 6…ystem K041509 ANKYLOS® Dental Implant System K072570 NobelActive Multi-Unit Abutment K093643 Multi-Unit Abutments for Straumann and Astra Tech Implant Systems K072878 Locator Implant Anchor K092434 2.2 mm Angled Micro ERA Dental Implant System K120414 OsseoSpeedTM Plus K083496 CAMLOG… | 2007 |
| * | K092434 | Sterngold 2.2MM Angles Micro Era Dental Implant SystemSummary page 6…Implant System K072570 NobelActive Multi-Unit Abutment K093643 Multi-Unit Abutments for Straumann and Astra Tech Implant Systems K072878 Locator Implant Anchor K092434 2.2 mm Angled Micro ERA Dental Implant System K120414 OsseoSpeedTM Plus K083496 CAMLOG Implant System Modified Implants… | 2009 |
| * | K120414 | Osseospeed PlusSummary page 6…t K093643 Multi-Unit Abutments for Straumann and Astra Tech Implant Systems K072878 Locator Implant Anchor K092434 2.2 mm Angled Micro ERA Dental Implant System K120414 OsseoSpeedTM Plus K083496 CAMLOG Implant System Modified Implants and Abutments K080239 P.004 RC/NC Bar and Bridge Abutm… | 2012 |
| * | K083496 | Camlog Implant System Modified Implants and AbutmentsSummary page 6…ents for Straumann and Astra Tech Implant Systems K072878 Locator Implant Anchor K092434 2.2 mm Angled Micro ERA Dental Implant System K120414 OsseoSpeedTM Plus K083496 CAMLOG Implant System Modified Implants and Abutments K080239 P.004 RC/NC Bar and Bridge Abutments Line Non-clinical test… | 2009 |
| * | K080239 | P.004 Abutments, P.004 Temporary Copings, P.004 Protective Caps, P.004 Permanent CopingsSummary page 6…tor Implant Anchor K092434 2.2 mm Angled Micro ERA Dental Implant System K120414 OsseoSpeedTM Plus K083496 CAMLOG Implant System Modified Implants and Abutments K080239 P.004 RC/NC Bar and Bridge Abutments Line Non-clinical testing data submitted, referenced, or relied upon to demonstrate sub… | 2008 |
What descends from it? (7)
2 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 25 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 26 of the 210 ancestors have a recall of any class.
- Of its descendants, K223113 (Medentika GmbH, 2024) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K020646.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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. Abutments are compatible with the following implant systems: Nobel Biocare Replace Select, E-Series, implant diameters 3.5, 4.3, 5.0, 6.0 mm Nobel Biocare NobelActive, F-Series, implant diameters 3.5, 4.3, 5.0 mm Biomet 3i Osseotite Certain, H-Series, implant diameters…
Read the full statement (157 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.
Abutments are compatible with the following implant systems:
Nobel Biocare Replace Select, E-Series, implant diameters 3.5, 4.3, 5.0, 6.0 mm
Nobel Biocare NobelActive, F-Series, implant diameters 3.5, 4.3, 5.0 mm
Biomet 3i Osseotite Certain, H-Series, implant diameters 3.25, 4.0, 5.0 mm
Biomet 3i Osseotite, I-Series, implant diameters 3.25, 3.75, 4.0, 5.0 mm
Nobel Biocare Branemark, K-Series, implant diameters 3.3, 3.75, 4.0, 5.0 mm
Straumann Bone Level, L-Series, implant diameters 3.3, 4.1, 4.8 mm
Straumann Standard, N-Series, implant diameters 3.3, 4.1, 4.8 mm
Zimmer Tapered Screw-vent, R-Series, implant diameters 3.3, 3.7, 4.1, 4.7, 6.0 mm
Astra Tech OsseoSpeed, S-Series, implant diameters 3.5, 4.0, 4.5, 5.0 mm
Dentsply Friadent Frialit/Xive, T-Series, implant diameters 3.4, 3.8, 4.5, 5.5 mm
Dentsply Friadent Ankylos, Y-Series, implant diameters 3.5, 4.5, 5.5, 7.0 mm
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142167 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142167: Medentika Abutment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142167
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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