510(k) · Cleared
ClearedCustom Abutments AS
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 Dec 23, 2025 as substantially equivalent to K223113 (Medentika GmbH, 2024) after an 84-day review. Its family tree reaches back 14 generations to 1990.
- Decided
- Dec 23, 2025
- Review
- 84 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K894595 (1990). 212 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 14 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 10 generations between
- 3 generations backK120414 Osseospeed PlusAstra Tech AB · 2012
- 2 generations backK142167 Medentika Abutment SystemMedentika GmbH · 2015
- 1 generation backK223113 Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika…Medentika GmbH · 2024
- This deviceK253341 Custom Abutments ASMedentika GmbH · 2025
Show all 14 generations
- Root · 14 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 13 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 12 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 11 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 10 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 9 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 8 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 7 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 6 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- 5 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- 4 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- 3 generations backK120414 Osseospeed PlusAstra Tech AB · 2012
- 2 generations backK142167 Medentika Abutment SystemMedentika GmbH · 2015
- 1 generation backK223113 Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika…Medentika GmbH · 2024
- This deviceK253341 Custom Abutments ASMedentika GmbH · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −13 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −12 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −11 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −10 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −9 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −8 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −7 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −6 | K101732 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −5 | K111287 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −4 | K112138 | Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant | Astra Tech, Inc. | 2011 | — |
| −3 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| −2 | K142167 | Medentika Abutment System | Medentika GmbH | 2015 | — |
| −1 | K223113 | Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM… | Medentika GmbH | 2024 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K223113 | Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Summary page 7…K253341 Traditional 510(k) Submission Custom Abutments AS 510(k) Summary • K223113 – Medentika CAD/CAM Abutments o Custom Abutments Series E, EV, F, and OT with a straight screw channel Referenc… | 2024 |
| † | K150203 | Medentika CAD/CAM Abutments | 2015 |
| † | K242542 | Medentika CAD/CAM Abutments | 2025 |
| † | K180564 | Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases | 2019 |
| † | K170838 | Medentika CAD/CAM TiBases | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 35 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 26 of the 212 ancestors have a recall of any class.
- 2 other devices also cite its predicate K223113.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Custom Abutments AS (Angulated Screw Channel) are intended for use with dental implants as a support for single or multiple tooth protheses in the maxilla or mandible of a partially or fully edentulous patient. Medentika Custom Abutments AS are intended for use with the Straumann® CARES® System. All digitally designed Medentika Custom Abutments AS are intended to be manufactured at a Straumann® validated milling center. The final patient…
Read the full statement (115 words)
Medentika Custom Abutments AS (Angulated Screw Channel) are intended for use with dental implants as a support for single or multiple tooth protheses in the maxilla or mandible of a partially or fully edentulous patient. Medentika Custom Abutments AS are intended for use with the Straumann® CARES® System. All digitally designed Medentika Custom Abutments AS are intended to be manufactured at a Straumann® validated milling center. The final patient matched form is a Custom Abutment AS.
Medentika abutments for the Nobel Biocare Nobel Active® 3.0 mm, Dentsply Sirona Astra Tech OsseoSpeed EV® 3.0 mm and TX® 3.0 mm, and Straumann Bone Level 2.9 implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253341 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253341: Custom Abutments AS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253341
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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