510(k) · Cleared
ClearedMedentika CAD/CAM 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 Oct 23, 2015 as substantially equivalent to K120822 (Institut Straumann AG, 2012) and 1 other predicate after a 267-day review. Its family tree reaches back 13 generations to 1990. 129 later devices descend from it.
- Decided
- Oct 23, 2015
- Review
- 267 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K894844 (1990). 170 ancestors in all, the oldest K871863 (1987). 129 later devices descend from it, 14 citing it directly.
- Root · 13 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 9 generations between
- 3 generations backK093113 Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG · 2009
- 2 generations backK101465 Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010
- 1 generation backK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- This deviceK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
- Descendant · cites it directly · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- Descendant · 2 generations on · 51 of its ownK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- Descendant · 2 generations on · 38 of its ownK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
- Descendant · 2 generations on · 22 of its ownK183518 Preat AbutmentsPreat Corporation · 2019 · Recalled
- Descendant · 2 generations on · 20 of its ownK212628 DESS Dental Smart SolutionsTerrats Medical SL · 2022
Show all 13 generations
- Root · 13 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 12 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 11 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 10 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 9 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 8 generations backK052272 Straumann Computer Aided Restoration ServiceStraumann USA · 2006
- 7 generations backK061277 Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic…Straumann USA · 2007
- 6 generations backK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
- 5 generations backK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- 4 generations backK082545 Straumann NN Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008
- 3 generations backK093113 Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG · 2009
- 2 generations backK101465 Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010
- 1 generation backK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- This deviceK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
Showing 5 of 129 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 129 · See all- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · cites it directly86descendants
- K173908DESS Dental Smart SolutionsTerrats Medical SL · 2018 · 2 generations on51descendants
- K191986DESS Dental Smart SolutionsTerrats Medical SL · 2019 · 2 generations on38descendants
- K183518Preat AbutmentsPreat Corporation · 2019 · 2 generations on22descendants
- K212628DESS Dental Smart SolutionsTerrats Medical SL · 2022 · 2 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −12 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −11 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −10 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −9 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −8 | K052272 | Straumann Computer Aided Restoration Service | Straumann USA | 2006 | — |
| −7 | K061277 | Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping | Straumann USA | 2007 | — |
| −6 | K072151 | P.004 RC Cares Titanium and Ceramic Abutments | Straumann USA | 2007 | 1 |
| −5 | K081005 | P.004 NC Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | 1 |
| −4 | K082545 | Straumann NN Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | — |
| −3 | K093113 | Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam Abutment | Institut Straumann AG | 2009 | — |
| −2 | K101465 | Straumann Cares Bridge; Straumann Cares Dolder Bar | Institut Straumann AG | 2010 | — |
| −1 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
| 0 (this device) | K150203 | Medentika CAD/CAM Abutments | Medentika GmbH | 2015 | — |
| +1 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| +2 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
| +2 | K191986 | DESS Dental Smart Solutions | Terrats Medical SL | 2019 | — |
| +2 | K183518 | Preat Abutments | Preat Corporation | 2019 | 3 |
| +2 | K212628 | DESS Dental Smart Solutions | Terrats Medical SL | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 12 | 0 |
| 1994 | 11 | 0 |
| 1995 | 8 | 0 |
| 1996 | 13 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 7 | 0 |
| 2000 | 6 | 0 |
| 2001 | 9 | 0 |
| 2002 | 12 | 0 |
| 2003 | 8 | 0 |
| 2004 | 9 | 0 |
| 2005 | 8 | 0 |
| 2006 | 13 | 0 |
| 2007 | 11 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 5 | 0 |
| 2019 | 7 | 0 |
| 2020 | 11 | 0 |
| 2021 | 10 | 0 |
| 2022 | 12 | 0 |
| 2023 | 23 | 0 |
| 2024 | 21 | 0 |
| 2025 | 24 | 0 |
| 2026 | 11 | 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? (2)
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 |
|---|---|---|---|
| * | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Summary page 6…tion Panel Dental Products Panel Reviewing Branch Dental Devices Branch PREDICATES The primary predicate for the Medentika TiBase is K120822, Straumann® CARES® Variobase™ Abutment. The primary predicate for the Medentika PreFace is K052272, Straumann C.A.R.E.S. Titanium… | 2012 |
| * | K052272 | Straumann Computer Aided Restoration ServiceSummary page 6…ge 6 === PREDICATES The primary predicate for the Medentika TiBase is K120822, Straumann® CARES® Variobase™ Abutment. The primary predicate for the Medentika PreFace is K052272, Straumann C.A.R.E.S. Titanium Abutment. Reference Predicates: K111935 Ti-Base for individual milled Zirconium Abut… | 2006 |
| † | K111935 | TI-Base Abutment, 1 Connect Abutment | 2012 |
| † | K082545 | Straumann NN Cares Titanium and Ceramic Abutments | 2008 |
| † | K083192 | Inclusive Titanium Abutment Blanks | 2009 |
| † | K073713 | Blue Sky Bio Dental Implant System | 2008 |
| † | K020646 | Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162, 50102… | 2002 |
| † | K071370 | Nobelactive Internal Connection Implant | 2007 |
| † | K102436 | Nobel Active 3.0 | 2010 |
| † | K063341 | 3I Osseotite Certain Dental Implants | 2007 |
| † | K063286 | Osseotite; Osseotite NT; XP; TG Osseotite | 2007 |
| † | K022562 | Various Branemark System Implants-Immediate Function Indication | 2002 |
| † | K062129 | P.0004 Implants | 2006 |
| † | K130222 | Straumann Dental Implant System | 2013 |
| † | K061410 | Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant… | 2006 |
| † | K101732 | Astra Tech Implant System | 2011 |
| † | K073075 | Frialit Plus, Xive S Plus, Xive TG Plus, Ankylos Plus, Dental Implant Systems | 2008 |
| † | K041509 | Ankylos Dental Implant System | 2004 |
What descends from it? (129)
See all 12914 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170588 | DESS Dental Smart Solutions | 2017 | 86 |
| K171799 | Elos Accurate Customized Abutment, Elos Prosthetic Screw | 2018 | 15 |
| K181037 | DIO CAD/CAM Abutment | 2018 | 7 |
| K220562 | TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment | 2022 | 5 |
| K162890 | BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC… | 2017 | 5 |
| K170838 | Medentika CAD/CAM TiBases | 2017 | 4 |
| K161713 | Dentium CAD/CAM Abutments | 2016 | 3 |
| K180564 | Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases | 2019 | 2 |
| K160784 | CAM Titanium Blanks | 2016 | 1 |
| K242542 | Medentika CAD/CAM Abutments | 2025 | 0 |
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 4 companies; a new generation was cleared every 1.3 years on median.
- 18 of the 170 ancestors have a recall of any class.
- Of its descendants, K170588 (Terrats Medical SL, 2017) has gone furthest, with 86 descendants of its own.
- 8 other devices also cite its predicate K120822.
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 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. Implant System Compatibility — Series — Implant Diameter (mm) — Platform Diameter (mm) Nobel Biocare Replace™ Select — E — 3.5, 4.3, 5.0, 6.0 — 3.5, 4.3, 5.0, 6.0 Nobel Biocare NobelActive™ — F — 3.5, 4.3, 5.0 — 3.5, 3.9 (4.3), 3.9 (5.0) Biomet 3i…
Read the full statement (465 words)
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.
Implant System Compatibility — Series — Implant Diameter (mm) — Platform Diameter (mm)
Nobel Biocare Replace™ Select — E — 3.5, 4.3, 5.0, 6.0 — 3.5, 4.3, 5.0, 6.0
Nobel Biocare NobelActive™ — F — 3.5, 4.3, 5.0 — 3.5, 3.9 (4.3), 3.9 (5.0)
Biomet 3i Osseotite® Certain® — H — 3.25, 4.0, 5.0 — 3.4, 4.1, 5.0
Biomet 3i Osseotite® — I — 3.25, 3.75, 4.0, 5.0 — 3.4, 4.1, 5.0
Nobel Biocare Brånemark — K — 3.3, 3.75, 4.0, 5.0 — 3.5, 4.1, 4.1, 5.1
Straumann Bone Level — L — 3.3, 4.1, 4.8 — 3.3, 4.1, 4.8
Straumann Standard — N — 3.3, 4.1, 4.8 — 3.5( NNC), 4.8, 6.5
Zimmer Tapered Screw-vent® — R — 3.3, 3.7, 4.1, 4.7, 6.0 — 3.5, 4.5, 5.7
Astra Tech OsseoSpeed™ — S — 3.5, 4.0, 4.5, 5.0 — 3.5, 4.0, 4.5, 5.0
Dentsply Friadent® Frialit/XiVE® — T — 3.4, 3.8, 4.5, 5.5 — 3.4, 3.8, 4.5, 5.5
Dentsply Friadent® Ankylos® — Y — 3.5, 4.5, 5.5, 7.0 — 3.5, 4.5, 5.5, 7.0
Medentika TiBase 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.
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.
Implant System Compatibility — Series — Implant Diameter (mm) — Platform Diameter (mm)
Nobel Biocare Replace™ Select — E — 3.5, 4.3, 5.0, 6.0 — 3.5, 4.3, 5.0, 6.0
Nobel Biocare NobelActive™ — F — 3.0, 3.5, 4.3, 5.0 — 3.0, 3.5, 3.9 (4.3), 3.9 (5.0)
Biomet 3i Osseotite® Certain® — H — 3.25, 4.0, 5.0 — 3.4, 4.1, 5.0
Biomet 3i Osseotite® — I — 3.25, 3.75, 4.0, 5.0 — 3.4, 4.1, 5.0
Nobel Biocare Brånemark — K — 3.3, 3.75, 4.0, 5.0 — 3.5, 4.1, 4.1, 5.1
Straumann Bone Level — L — 3.3, 4.1, 4.8 — 3.3, 4.1, 4.8
Straumann Standard — N — 3.3, 4.1, 4.8 — 3.5( NNC), 4.8, 6.5
Zimmer Tapered Screw-vent® — R — 3.3, 3.7, 4.1, 4.7, 6.0 — 3.5, 4.5, 5.7
Astra Tech OsseoSpeed™ — S — 3.0, 3.5, 4.0, 4.5, 5.0 — 3.0, 3.5, 4.0, 4.5, 5.0
Dentsply Friadent® Frialit/XiVE® — T — 3.4, 3.8, 4.5, 5.5 — 3.4, 3.8, 4.5, 5.5
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150203 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150203: Medentika CAD/CAM Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150203
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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