510(k) · Cleared
ClearedInclusive Titanium Abutments, Compatible with Dentsply Implants Ankylos C/X
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prismatik Dentalcraft, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jan 6, 2015 as substantially equivalent to K101004 (Astra Tech, Inc., 2010) and 1 other predicate after a 174-day review. Its family tree reaches back 10 generations to 1995.
- Decided
- Jan 6, 2015
- Review
- 174 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K944964 (1995). 84 ancestors in all, the oldest K871863 (1987). No later device cites it as a predicate yet.
- Root · 10 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 6 generations between
- 3 generations backK052070 Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia…Atlantis Components, Inc. · 2005
- 2 generations backK093780 Atlantis Abutment for Dentsply Implant, Atlantis Gemini Abutment…Astra Tech, Inc. · 2010
- 1 generation backK101004 Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini…Astra Tech, Inc. · 2010
- This deviceK141923 Inclusive Titanium Abutments, Compatible with Dentsply Implants…Prismatik Dentalcraft, Inc. · 2015
Show all 10 generations
- Root · 10 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 9 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 8 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 7 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 6 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 5 generations backK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
- 4 generations backK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
- 3 generations backK052070 Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia…Atlantis Components, Inc. · 2005
- 2 generations backK093780 Atlantis Abutment for Dentsply Implant, Atlantis Gemini Abutment…Astra Tech, Inc. · 2010
- 1 generation backK101004 Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini…Astra Tech, Inc. · 2010
- This deviceK141923 Inclusive Titanium Abutments, Compatible with Dentsply Implants…Prismatik Dentalcraft, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −9 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −8 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −7 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −6 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −5 | K032263 | 3I Patient-Specific Dental Abutment and Overdenture Bar | Implant Innovations, Inc. | 2004 | 1 |
| −4 | K042658 | Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004… | Nobel Biocare Uas, Inc. | 2004 | — |
| −3 | K052070 | Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis… | Atlantis Components, Inc. | 2005 | — |
| −2 | K093780 | Atlantis Abutment for Dentsply Implant, Atlantis Gemini Abutment, Atlantis… | Astra Tech, Inc. | 2010 | — |
| −1 | K101004 | Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment… | Astra Tech, Inc. | 2010 | — |
| 0 (this device) | K141923 | Inclusive Titanium Abutments, Compatible with Dentsply Implants Ankylos C/X | Prismatik Dentalcraft, Inc. | 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 | 9 | 0 |
| 1995 | 5 | 0 |
| 1996 | 7 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 8 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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? (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 |
|---|---|---|---|
| * | K101004 | Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment, Atlantis…Summary page 5…12 C. IDENTIFICATION OF PREDICATE DEVICE Trade/Proprietary Name: Atlantis Abutment for Dentsply Ankylos Implant (K101004) Inclusive Titanium Abutment Blanks (K083192) D. DEVICE DESCRIPTION Inclusive Titanium Abut… | 2010 |
| * | K083192 | Inclusive Titanium Abutment BlanksSummary page 5…PREDICATE DEVICE Trade/Proprietary Name: Atlantis Abutment for Dentsply Ankylos Implant (K101004) Inclusive Titanium Abutment Blanks (K083192) D. DEVICE DESCRIPTION Inclusive Titanium Abutments are endosseous implant abutments which are placed into the dent… | 2009 |
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 20 years and passes through 6 companies; a new generation was cleared every 12 months on median.
- 12 of the 84 ancestors have a recall of any class.
- 1 other device also cites its predicate K101004.
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?
Inclusive® Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
Inclusive Titanium Abutments are compatible with Dentsply Implants Ankylos® C/X in 3.5, 4.5, 5.5, 7.0 mm sizes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141923 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141923: Inclusive Titanium Abutments, Compatible with Dentsply Implants Ankylos C/X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141923
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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