510(k) · Cleared
ClearedInclusive Zirconia Abutment Blanks
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inclusive Dental Solutions · NHA Abutment, Implant, Dental, Endosseous
Cleared on May 5, 2009 as substantially equivalent to K072642 (Biomet 3i, Inc., 2007) and 5 other predicates after a 162-day review. Its family tree reaches back 10 generations to 1995. 27 later devices descend from it.
- Decided
- May 5, 2009
- Review
- 162 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 10 generations to K944964 (1995). 100 ancestors in all, the oldest K781060 (1978). 27 later devices descend from it, 2 citing it directly.
- 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 backK063734 Atlantis Abutment in Zirconia for 3I Certain InterfaceAtlantis Components, Inc. · 2007
- 1 generation backK072483 Atlantis Abutment in Zirconia for 3I Certain Microamini Implants…Atlantis Components, Inc. · 2007
- This deviceK083480 Inclusive Zirconia Abutment BlanksInclusive Dental Solutions · 2009
- Descendant · cites it directly · 25 of its ownK132125 A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014
- Descendant · 2 generations on · 14 of its ownK140440 Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014
- Descendant · 3 generations on · 7 of its ownK151909 Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016
- Descendant · 2 generations on · 4 of its ownK162482 A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd. · 2017
- Descendant · 3 generations on · 2 of its ownK183024 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020
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 backK063734 Atlantis Abutment in Zirconia for 3I Certain InterfaceAtlantis Components, Inc. · 2007
- 1 generation backK072483 Atlantis Abutment in Zirconia for 3I Certain Microamini Implants…Atlantis Components, Inc. · 2007
- This deviceK083480 Inclusive Zirconia Abutment BlanksInclusive Dental Solutions · 2009
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014 · cites it directly25descendants
- K140440Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014 · 2 generations on14descendants
- K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016 · 3 generations on7descendants
- K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd. · 2017 · 2 generations on4descendants
- K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020 · 3 generations on2descendants
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 | K063734 | Atlantis Abutment in Zirconia for 3I Certain Interface | Atlantis Components, Inc. | 2007 | — |
| −1 | K072483 | Atlantis Abutment in Zirconia for 3I Certain Microamini Implants, Gemini… | Atlantis Components, Inc. | 2007 | — |
| 0 (this device) | K083480 | Inclusive Zirconia Abutment Blanks | Inclusive Dental Solutions | 2009 | — |
| +1 | K132125 | A.B. Dental Devices Dental Implants System | A.B. Dental Devices, Ltd. | 2014 | — |
| +2 | K140440 | Noris Medical Dental Implants System | Noris Medical, Ltd. | 2014 | — |
| +3 | K151909 | Noris Medical Zygomatic Dental Implant System | Noris Medical, Ltd. | 2016 | — |
| +2 | K162482 | A.B. DENTAL DEVICES Dental Implants System | A.B. Dental Device, Ltd. | 2017 | — |
| +3 | K183024 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | 2020 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 30.7 · 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? (6)
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 |
|---|---|---|---|
| * | K072642 | Biomet 3I Dental Abutments and Restorative ComponentsSummary page 1…ally equivalent to other legally marketed devices in the United States. Substantially equivalent devices include the following: Biomnet 3i Dental Abutments cleared under K072642; for Zimmer, Biomet3i and Nobel Biocare implants cleared under KOI11028, K063341, and K0231 13 respectively; AtlantiSTm Abutment… | 2007 |
| * | K011028 | Screw-Vent Dental Implant System | 2001 |
| * | K063341 | 3I Osseotite Certain Dental ImplantsSummary page 1…ally equivalent devices include the following: Biomnet 3i Dental Abutments cleared under K072642; for Zimmer, Biomet3i and Nobel Biocare implants cleared under KOI11028, K063341, and K0231 13 respectively; AtlantiSTm Abutment in Zirenia for Nobel Biocare Replace (K062277); and, AtlantiSTm Abutment in Zirco… | 2007 |
| * | K023113 | Replace Tiunite Endosseous ImplantSummary page 1…nt devices include the following: Biomnet 3i Dental Abutments cleared under K072642; for Zimmer, Biomet3i and Nobel Biocare implants cleared under KOI11028, K063341, and K0231 13 respectively; AtlantiSTm Abutment in Zirenia for Nobel Biocare Replace (K062277); and, AtlantiSTm Abutment in Zirconia for 3i Cer… | 2002 |
| * | K062277 | Atlantis Abutment in Zirconia for Nobel Biocare ReplaceSummary page 1…42; for Zimmer, Biomet3i and Nobel Biocare implants cleared under KOI11028, K063341, and K0231 13 respectively; AtlantiSTm Abutment in Zirenia for Nobel Biocare Replace (K062277); and, AtlantiSTm Abutment in Zirconia for 3i Certain (K072483). Safety and Efficacy: The device functions in a similar manner t… | 2006 |
| * | K072483 | Atlantis Abutment in Zirconia for 3I Certain Microamini Implants, Gemini Abutment in…Summary page 1…er KOI11028, K063341, and K0231 13 respectively; AtlantiSTm Abutment in Zirenia for Nobel Biocare Replace (K062277); and, AtlantiSTm Abutment in Zirconia for 3i Certain (K072483). Safety and Efficacy: The device functions in a similar manner to other comparative devices and the intended use is the same. T… | 2007 |
What descends from it? (27)
See all 272 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 5 companies; a new generation was cleared every 12 months on median.
- 14 of the 100 ancestors have a recall of any class.
- Of its descendants, K132125 (A.B. Dental Devices, Ltd., 2014) has gone furthest, with 25 descendants of its own.
- 11 other devices also cite its predicate K072642.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
The Inclusive Zirconia Abutment Blank is intended to be used in conjunction with endosseous implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdenture prostheses. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. Inclusive Zirconia Abutment Blanks for Zimmer Implants are compatible with Zimmer Screw Vent and Tapered Screw Vent…
Read the full statement (115 words)
The Inclusive Zirconia Abutment Blank is intended to be used in conjunction with endosseous implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdenture prostheses. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
Inclusive Zirconia Abutment Blanks for Zimmer Implants are compatible with Zimmer Screw Vent and Tapered Screw Vent internal hex implants. Inclusive Zirconia Abutment Blanks for 3i Implant are compatible with 3i Certain internal hex implants. Inclusive Zirconia Abutment Blanks for Nobel Biocare Implant are compatible with Nobel Biocare Replace straight and tapered internal-connection implants.
Abutments with angulations greater than 20 degrees are contraindicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083480 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083480: Inclusive Zirconia Abutment Blanks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083480
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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