510(k) · Cleared
ClearedInclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants
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 Oct 1, 2015 as substantially equivalent to K083480 (Inclusive Dental Solutions, 2009) after a 294-day review. Its family tree reaches back 11 generations to 1995.
- Decided
- Oct 1, 2015
- Review
- 294 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K944964 (1995). 101 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 11 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 7 generations between
- 3 generations backK063734 Atlantis Abutment in Zirconia for 3I Certain InterfaceAtlantis Components, Inc. · 2007
- 2 generations backK072483 Atlantis Abutment in Zirconia for 3I Certain Microamini Implants…Atlantis Components, Inc. · 2007
- 1 generation backK083480 Inclusive Zirconia Abutment BlanksInclusive Dental Solutions · 2009
- This deviceK143515 Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent…Prismatik Dentalcraft, Inc. · 2015
Show all 11 generations
- Root · 11 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 10 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 9 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 8 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 7 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 6 generations backK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
- 5 generations backK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
- 4 generations backK052070 Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia…Atlantis Components, Inc. · 2005
- 3 generations backK063734 Atlantis Abutment in Zirconia for 3I Certain InterfaceAtlantis Components, Inc. · 2007
- 2 generations backK072483 Atlantis Abutment in Zirconia for 3I Certain Microamini Implants…Atlantis Components, Inc. · 2007
- 1 generation backK083480 Inclusive Zirconia Abutment BlanksInclusive Dental Solutions · 2009
- This deviceK143515 Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent…Prismatik Dentalcraft, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −10 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −9 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −8 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −7 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −6 | K032263 | 3I Patient-Specific Dental Abutment and Overdenture Bar | Implant Innovations, Inc. | 2004 | 1 |
| −5 | K042658 | Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004… | Nobel Biocare Uas, Inc. | 2004 | — |
| −4 | K052070 | Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis… | Atlantis Components, Inc. | 2005 | — |
| −3 | K063734 | Atlantis Abutment in Zirconia for 3I Certain Interface | Atlantis Components, Inc. | 2007 | — |
| −2 | K072483 | Atlantis Abutment in Zirconia for 3I Certain Microamini Implants, Gemini… | Atlantis Components, Inc. | 2007 | — |
| −1 | K083480 | Inclusive Zirconia Abutment Blanks | Inclusive Dental Solutions | 2009 | — |
| 0 (this device) | K143515 | Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i… | Prismatik Dentalcraft, Inc. | 2015 | — |
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 | 5 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 9 | 0 |
| 1994 | 9 | 0 |
| 1995 | 8 | 0 |
| 1996 | 7 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 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 |
|---|---|---|---|
| * | K083480 | Inclusive Zirconia Abutment BlanksSummary page 4…2 Review Panel: Dental C. IDENTIFICATION OF PREDICATE DEVICE Trade/Proprietary Name: Inclusive Zirconia Abutment Blanks (K083480) D. DEVICE DESCRIPTION Inclusive Zirconia 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.
- 14 of the 101 ancestors have a recall of any class.
- 1 other device also cites its predicate K083480.
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® Zirconia Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
Inclusive® Zirconia Abutments are compatible with the following bone-level implants:
Biomet 3i™ Certain® internal hex implants with 3.4, 4.1, 5.0, 6.0 mm platform diameters
Nobel Biocare NobelReplace® straight and tapered internal connection implants with NP, RP, WP, 6.0 mm platform diameters
Zimmer Dental Screw-Vent® and Tapered Screw-Vent® internal hex implants with 3.5, 4.5, 5.7 mm platform diameters (excluding 3.3 mmD Screw-Vent implants)
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K143515 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143515: Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143515
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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