510(k) · Cleared
Recalled · Class II · 2025Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel Biocare Implant
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 Nov 13, 2014 as substantially equivalent to K073217 (Inclusive Dental Solutions, 2008) and 3 other predicates after a 101-day review. Its family tree reaches back 10 generations to 1993. 2 later devices descend from it. It has been recalled once.
- Decided
- Nov 13, 2014
- Review
- 101 days
- Class
- Class II
- Product code
- NHA
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 10 generations to K925765 (1993). 124 ancestors in all, the oldest K781060 (1978). 2 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 6 generations between
- 3 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 2 generations backK063341 3I Osseotite Certain Dental ImplantsImplant Innovations, Inc. · 2007 · Recalled
- 1 generation backK073217 Inclusive Implant AbutmentsInclusive Dental Solutions · 2008
- This deviceK142115 Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and…Prismatik Dentalcraft, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK151295 Biodenta Customized Abutment - TitaniumBiodenta Swiss AG · 2015
- Descendant · 2 generations on · 0 of its ownK231210 DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd. · 2024
Show all 10 generations
- Root · 10 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 9 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 8 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 7 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 6 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- 5 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- 4 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 3 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 2 generations backK063341 3I Osseotite Certain Dental ImplantsImplant Innovations, Inc. · 2007 · Recalled
- 1 generation backK073217 Inclusive Implant AbutmentsInclusive Dental Solutions · 2008
- This deviceK142115 Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and…Prismatik Dentalcraft, Inc. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −9 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −8 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −7 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −6 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| −5 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| −4 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −3 | K051461 | 3I Osseotite Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −2 | K063341 | 3I Osseotite Certain Dental Implants | Implant Innovations, Inc. | 2007 | 10 |
| −1 | K073217 | Inclusive Implant Abutments | Inclusive Dental Solutions | 2008 | — |
| 0 (this device) | K142115 | Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel… | Prismatik Dentalcraft, Inc. | 2014 | — |
| +1 | K151295 | Biodenta Customized Abutment - Titanium | Biodenta Swiss AG | 2015 | — |
| +2 | K231210 | DGA Abutment | Modern Dental Laboratory (Dg) Co., Ltd. | 2024 | — |
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 | 2 | 0 |
| 1993 | 9 | 0 |
| 1994 | 9 | 0 |
| 1995 | 11 | 0 |
| 1996 | 11 | 0 |
| 1997 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 6 | 0 |
| 2000 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 7 | 0 |
| 2003 | 4 | 0 |
| 2004 | 6 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2009 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2024 | 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? (4)
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 |
|---|---|---|---|
| * | K073217 | Inclusive Implant AbutmentsSummary page 5…4 C. IDENTIFICATION OF PREDICATE DEVICE Trade/Proprietary Name: InclusiveTM Abutment for Zimmer, 3i and Nobel Biocare Implants (K073217) NobelProcera Ti Abutment (K091756) BIOMET 3i Dental Abutments and Restorative Components (K072642) Zimme… | 2008 |
| * | K091756 | Nobelprocera TI AbutmentSummary page 5…TION OF PREDICATE DEVICE Trade/Proprietary Name: InclusiveTM Abutment for Zimmer, 3i and Nobel Biocare Implants (K073217) NobelProcera Ti Abutment (K091756) BIOMET 3i Dental Abutments and Restorative Components (K072642) Zimmer Ti Prepable Abutment (K092403). D. DEV… | 2009 |
| * | K072642 | Biomet 3I Dental Abutments and Restorative ComponentsSummary page 5…TM Abutment for Zimmer, 3i and Nobel Biocare Implants (K073217) NobelProcera Ti Abutment (K091756) BIOMET 3i Dental Abutments and Restorative Components (K072642) Zimmer Ti Prepable Abutment (K092403). D. DEVICE DESCRIPTION Inclusive Titanium Abutments are endosseous implan… | 2007 |
| * | K092403 | TI Prepable Abutment, Model 1618, 1619, 1620Summary page 5…mplants (K073217) NobelProcera Ti Abutment (K091756) BIOMET 3i Dental Abutments and Restorative Components (K072642) Zimmer Ti Prepable Abutment (K092403). D. DEVICE DESCRIPTION Inclusive Titanium Abutments are endosseous implant abutments which are placed into the den… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151295 | Biodenta Customized Abutment - Titanium | 2015 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 30, 2025 | Class II | Z-0417-2026 | Employee error | Incorrect titanium screw, packaged with dental implant. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 1.0 years on median.
- 16 of the 124 ancestors have a recall of any class.
- Of its descendants, K151295 (Biodenta Swiss AG, 2015) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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:
- Biomet: 3i Certain internal hex implants in 3.4, 4.1, 5.0, 6.0 mm sizes
- Nobel Biocare: NobelReplace straight and tapered internal connection implants in NP, RP, WP, 6.0 mm sizes
- Zimmer: Screw-Vent and Tapered Screw-Vent internal hex implants in 3.5, 4.5, 5.7 mm sizes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142115: Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel Biocare Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142115
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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