510(k) · Cleared
ClearedInclusive Abutments
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 4, 2016 after a 211-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- Nov 4, 2016
- Review
- 211 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK160979 Inclusive AbutmentsPrismatik Dentalcraft, Inc. · 2016
- Descendant · cites it directly · 5 of its ownK170044 Inclusive Titanium Abutments compatible with: MegaGen AnyRidge…Prismatik Dentalcraft, Inc. · 2017
- Descendant · 2 generations on · 4 of its ownK191222 Inclusive Titanium Abutments compatible with: Dentsply Implants…Prismatik Dentalcraft, Inc. · 2019
- Descendant · 3 generations on · 0 of its ownK252582 Inclusive® Titanium Abutments compatible with: Camlog® CONELOG®…Prismatik Dentalcraft, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK240240 Inclusive® Titanium Abutments compatible with: Keystone® Dental…Prismatik Dentalcraft, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK231097 Inclusive® Titanium Abutments compatible with: Neoss® ProActive®…Prismatik Dentalcraft, Inc. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant SystemPrismatik Dentalcraft, Inc. · 2017 · cites it directly5descendants
- K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc. · 2019 · 2 generations on4descendants
- K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc. · 2025 · 3 generations on0descendants
- K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc. · 2024 · 3 generations on0descendants
- K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K160979 | Inclusive Abutments | Prismatik Dentalcraft, Inc. | 2016 | — |
| +1 | K170044 | Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System | Prismatik Dentalcraft, Inc. | 2017 | — |
| +2 | K191222 | Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech… | Prismatik Dentalcraft, Inc. | 2019 | — |
| +3 | K252582 | Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant… | Prismatik Dentalcraft, Inc. | 2025 | — |
| +3 | K240240 | Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®… | Prismatik Dentalcraft, Inc. | 2024 | — |
| +3 | K231097 | Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow… | Prismatik Dentalcraft, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170044 | Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System | 2017 | 5 |
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?
- Of its descendants, K170044 (Prismatik Dentalcraft, Inc., 2017) has gone furthest, with 5 descendants 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. 2016, 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” Abutments are premanufactured prosthetic components connected to endosseous dental implants in the edentulous or partially edentulous maxilla or mandible to provide support for cement-retained or screw-retained prosthetic restorations. Compatible Implant System Implant Diameter (mm) Platform Diameter (mm) Astra Tech OsseoSpeed™ 3.0,3.5,4.0,4.5,5.0 3.0,3.5,4.0,4.5,5.0 Biomet 3i Osseotite” Certain” 3.25,4.0,5.0,6.0 3.4,4.1,5.0,6.0 Camlog…
Read the full statement (141 words)
Inclusive” Abutments are premanufactured prosthetic components connected to endosseous dental implants in the edentulous or partially edentulous maxilla or mandible to provide support for cement-retained or screw-retained prosthetic restorations.
Compatible Implant System Implant Diameter (mm) Platform Diameter (mm)
Astra Tech OsseoSpeed™ 3.0,3.5,4.0,4.5,5.0 3.0,3.5,4.0,4.5,5.0
Biomet 3i Osseotite” Certain” 3.25,4.0,5.0,6.0 3.4,4.1,5.0,6.0
Camlog Screw-line 3.3,3.8,4.3,5.0,6.0 3.3,3.8,4.3,5.0,6.0
Dentsply Ankylos 3.5,4.5,55,7.0 3.5,4.5,5.5,7.0
Hahn Tapered Implant System 3.0,3.5,4.3,5.0,7.0 3.0,3.5,4.3,5.0,7.0
Hiossen HG Implant System mini, standard 3.5,4.0,45,5.0 37,4.2,4.6,5.1
Inclusive Tapered Implant System 3.7,4.7,5.2 35,45
Nobel Biocare Branemark RP 3.75,4.0 4.1
Nobel Biocare NobelActive™ NP, RP 35,43,5.0 35,39
Nobel Biocare NobelReplace™ NP, RP, WP, 6.0 3.5,4.3,5.0,6.0 3.5,4.3,5.0,6.0
Straumann Bone Level NC, RC 33,4.1,4.8 33,4.1,4.8
Straumann synOcta RN, WN 4.1,4.8 4.8,6.5
Zimmer Screw-Vent® 37,4.1,4.7,6.0 3.5,4.5,5.7
All digitally designed abutments for use with Inclusive® Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K160979 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160979: Inclusive Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160979
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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