510(k) · Cleared
ClearedMedentika CAD/CAM TiBases
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 Sep 15, 2017 as substantially equivalent to K150203 (Medentika GmbH, 2015) after a 178-day review. Its family tree reaches back 14 generations to 1990. 4 later devices descend from it.
- Decided
- Sep 15, 2017
- Review
- 178 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K894844 (1990). 171 ancestors in all, the oldest K871863 (1987). 4 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 10 generations between
- 3 generations backK101465 Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010
- 2 generations backK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- 1 generation backK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
- This deviceK170838 Medentika CAD/CAM TiBasesMedentika GmbH · 2017
- 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 · cites it directly · 0 of its ownK242542 Medentika CAD/CAM AbutmentsMedentika GmbH · 2025
- Descendant · 3 generations on · 0 of its ownK230218 DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH · 2023
Show all 14 generations
- Root · 14 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 13 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 12 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 11 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 10 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 9 generations backK052272 Straumann Computer Aided Restoration ServiceStraumann USA · 2006
- 8 generations backK061277 Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic…Straumann USA · 2007
- 7 generations backK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
- 6 generations backK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- 5 generations backK082545 Straumann NN Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008
- 4 generations backK093113 Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG · 2009
- 3 generations backK101465 Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010
- 2 generations backK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- 1 generation backK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
- This deviceK170838 Medentika CAD/CAM TiBasesMedentika GmbH · 2017
Most influential descendants
Showing 4 of 4 · See all- 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
- K242542Medentika CAD/CAM AbutmentsMedentika GmbH · 2025 · cites it directly0descendants
- K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −13 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −12 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −11 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −10 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −9 | K052272 | Straumann Computer Aided Restoration Service | Straumann USA | 2006 | — |
| −8 | K061277 | Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping | Straumann USA | 2007 | — |
| −7 | K072151 | P.004 RC Cares Titanium and Ceramic Abutments | Straumann USA | 2007 | 1 |
| −6 | K081005 | P.004 NC Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | 1 |
| −5 | K082545 | Straumann NN Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | — |
| −4 | K093113 | Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam Abutment | Institut Straumann AG | 2009 | — |
| −3 | K101465 | Straumann Cares Bridge; Straumann Cares Dolder Bar | Institut Straumann AG | 2010 | — |
| −2 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
| −1 | K150203 | Medentika CAD/CAM Abutments | Medentika GmbH | 2015 | — |
| 0 (this device) | K170838 | Medentika CAD/CAM TiBases | Medentika GmbH | 2017 | — |
| +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 | — |
| +1 | K242542 | Medentika CAD/CAM Abutments | Medentika GmbH | 2025 | — |
| +3 | 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 |
|---|---|---|
| 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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K150203 | Medentika CAD/CAM AbutmentsSummary page 5…nal 510(k) Submission Medentika CAD/CAM TiBases 510(k) Summary Predicate Device Primary Predicate: K150203 – Medentika CAD/CAM Abutments, Medentika GmbH Reference Predicates: K142890 – Straumann® CARES® Variobase™ Abutments, Inst… | 2015 |
| † | K142890 | Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase… | 2015 |
| † | K051705 | Ips E.Max Cad/Ips E.Max Zircad | 2005 |
| † | K061804 | Zerion Alpha, ; Zerion Beta | 2006 |
| † | K162890 | BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC… | 2017 |
| † | K130436 | Multilink Hybrid Abutment Cement | 2013 |
What descends from it? (4)
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 27 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 18 of the 171 ancestors have a recall of any class.
- Of its descendants, K180564 (Medentika GmbH, 2019) has gone furthest, with 2 descendants of its own.
- 13 other devices also cite its predicate K150203.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170838 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170838: Medentika CAD/CAM TiBases.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170838
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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