510(k) · Cleared
ClearedDigitek Titanium Abutment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Digitek Dental Solutions Limited · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jul 31, 2015 as substantially equivalent to K100993 (Prismatik Dentalcraft, Inc., 2010) and 1 other predicate after a 375-day review. Its family tree reaches back 11 generations to 1990.
- Decided
- Jul 31, 2015
- Review
- 375 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K894595 (1990). 126 ancestors in all, the oldest K871863 (1987). No later device cites it as a predicate yet.
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations between
- 3 generations backK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- 2 generations backK083871 Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann…Astra Tech, Inc. · 2009
- 1 generation backK103234 GC Aadva BO AC AbutmentsGC America, Inc. · 2011
- This deviceK141970 Digitek Titanium AbutmentDigitek Dental Solutions Limited · 2015
Show all 11 generations
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 10 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 9 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 8 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 7 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 6 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 5 generations backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- 4 generations backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- 3 generations backK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- 2 generations backK083871 Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann…Astra Tech, Inc. · 2009
- 1 generation backK103234 GC Aadva BO AC AbutmentsGC America, Inc. · 2011
- This deviceK141970 Digitek Titanium AbutmentDigitek Dental Solutions Limited · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −10 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −9 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −8 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −7 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −6 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −5 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| −4 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| −3 | K060958 | Straumann Narrow Neck Implants | Straumann USA | 2006 | — |
| −2 | K083871 | Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann Bone Level… | Astra Tech, Inc. | 2009 | — |
| −1 | K103234 | GC Aadva BO AC Abutments | GC America, Inc. | 2011 | — |
| 0 (this device) | K141970 | Digitek Titanium Abutment | Digitek Dental Solutions Limited | 2015 | — |
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 |
| 1993 | 11 | 0 |
| 1994 | 10 | 0 |
| 1995 | 7 | 0 |
| 1996 | 11 | 0 |
| 1997 | 6 | 0 |
| 1998 | 7 | 0 |
| 1999 | 8 | 0 |
| 2000 | 3 | 0 |
| 2001 | 9 | 0 |
| 2002 | 10 | 0 |
| 2003 | 8 | 0 |
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2010 | 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 30.7 · 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 |
|---|---|---|---|
| * | K100993 | Inclusive Titanium Abutments for Astra Tech Osseospeed ImplantsSummary page 4…II Panel Dental 3. Predicated Devices Primary Predicate Inclusive® Titanium Abutment for - Astra OsseoSpeedTM Device Implants, K100993 Reference predicate GC AADVA TI ABUTMENTS – BO AC SV BH, K103234 Device 4. Device Description Digitek Titanium Abutments are e… | 2010 |
| * | K103234 | GC Aadva BO AC AbutmentsSummary page 4…ary Predicate Inclusive® Titanium Abutment for - Astra OsseoSpeedTM Device Implants, K100993 Reference predicate GC AADVA TI ABUTMENTS – BO AC SV BH, K103234 Device 4. Device Description Digitek Titanium Abutments are endosseous implant abutments which are placed into a corresponding… | 2011 |
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 25 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 14 of the 126 ancestors have a recall of any class.
- 4 other devices also cite its predicate K100993.
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?
Digitek Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the ASTRA TECH Implant System OsseoSpeed™ 3.5mm, 4.0mm, 4.5mm, 5.0mm implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141970 · printed Nov 4, 2026
Cite this page
510(k) Report. “K141970: Digitek Titanium Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K141970
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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