510(k) · Cleared
ClearedInclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System
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 Jun 6, 2017 as substantially equivalent to K160979 (Prismatik Dentalcraft, Inc., 2016) and 4 other predicates after a 152-day review. Its family tree reaches back 10 generations to 1995. 5 later devices descend from it.
- Decided
- Jun 6, 2017
- Review
- 152 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K944964 (1995). 94 ancestors in all, the oldest K874590 (1988). 5 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 6 generations between
- 3 generations backK070562 EZ Plus Implant SystemMegagen Co., Ltd. · 2007
- 2 generations backK110955 Anyridge Internal Implant SystemMegagen Co., Ltd. · 2011
- 1 generation backK140091 Xpeed Anyridge Internal Implant SysyemMegagen Implant Co., Ltd. · 2014
- This deviceK170044 Inclusive Titanium Abutments compatible with: MegaGen AnyRidge…Prismatik Dentalcraft, Inc. · 2017
- Descendant · cites it directly · 4 of its ownK191222 Inclusive Titanium Abutments compatible with: Dentsply Implants…Prismatik Dentalcraft, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK252582 Inclusive® Titanium Abutments compatible with: Camlog® CONELOG®…Prismatik Dentalcraft, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK240240 Inclusive® Titanium Abutments compatible with: Keystone® Dental…Prismatik Dentalcraft, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK231097 Inclusive® Titanium Abutments compatible with: Neoss® ProActive®…Prismatik Dentalcraft, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK223496 Inclusive® Titanium Abutments compatible with: Straumann® Bone Level…Prismatik Dentalcraft, Inc. · 2023
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 backK041655 Bio Plant System (Implants and Abutments)Cowellmedi Co., Ltd. · 2004
- 4 generations backK052369 Exfeel Implant SystemMegagen Co., Ltd. · 2006
- 3 generations backK070562 EZ Plus Implant SystemMegagen Co., Ltd. · 2007
- 2 generations backK110955 Anyridge Internal Implant SystemMegagen Co., Ltd. · 2011
- 1 generation backK140091 Xpeed Anyridge Internal Implant SysyemMegagen Implant Co., Ltd. · 2014
- This deviceK170044 Inclusive Titanium Abutments compatible with: MegaGen AnyRidge…Prismatik Dentalcraft, Inc. · 2017
Most influential descendants
Showing 5 of 5 · See all- K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc. · 2019 · cites it directly4descendants
- K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc. · 2025 · 2 generations on0descendants
- K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc. · 2024 · 2 generations on0descendants
- K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc. · 2023 · 2 generations on0descendants
- K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc. · 2023 · 2 generations on0descendants
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 | K041655 | Bio Plant System (Implants and Abutments) | Cowellmedi Co., Ltd. | 2004 | — |
| −4 | K052369 | Exfeel Implant System | Megagen Co., Ltd. | 2006 | — |
| −3 | K070562 | EZ Plus Implant System | Megagen Co., Ltd. | 2007 | — |
| −2 | K110955 | Anyridge Internal Implant System | Megagen Co., Ltd. | 2011 | — |
| −1 | K140091 | Xpeed Anyridge Internal Implant Sysyem | Megagen Implant Co., Ltd. | 2014 | — |
| 0 (this device) | K170044 | Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System | Prismatik Dentalcraft, Inc. | 2017 | — |
| +1 | K191222 | Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech… | Prismatik Dentalcraft, Inc. | 2019 | — |
| +2 | K252582 | Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant… | Prismatik Dentalcraft, Inc. | 2025 | — |
| +2 | K240240 | Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®… | Prismatik Dentalcraft, Inc. | 2024 | — |
| +2 | K231097 | Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow… | Prismatik Dentalcraft, Inc. | 2023 | — |
| +2 | K223496 | Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC… | Prismatik Dentalcraft, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 10 | 0 |
| 1994 | 7 | 0 |
| 1995 | 7 | 0 |
| 1996 | 7 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 7 | 0 |
| 2000 | 5 | 0 |
| 2001 | 6 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2010 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (5)
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 |
|---|---|---|---|
| * | K160979 | Inclusive AbutmentsSummary page 4…Class II, NHA Panel: Dental C. IDENTIFICATION OF PREDICATE DEVICE Primary Predicate: Inclusive Abutments (K160979) Reference Device: Inclusive® Titanium Abutments for Astra Oss… | 2016 |
| * | K140091 | Xpeed Anyridge Internal Implant SysyemSummary page 4…Astra OsseoSpeed Implants (K100993) XPEED AnyRidge Internal Implant System (K140091) Hahn Tapered Implant System (K143353) Inclus… | 2014 |
| * | K100993 | Inclusive Titanium Abutments for Astra Tech Osseospeed ImplantsSummary page 4…ive Abutments (K160979) Reference Device: Inclusive® Titanium Abutments for Astra OsseoSpeed Implants (K100993) XPEED AnyRidge Internal Implant System (K140… | 2010 |
| * | K143353 | Hahn Tapered Implant SystemSummary page 4…XPEED AnyRidge Internal Implant System (K140091) Hahn Tapered Implant System (K143353) Inclusive Tapered Implant System (K121406)… | 2015 |
| * | K121406 | Inclusive Tapered Implant SystemSummary page 4…Hahn Tapered Implant System (K143353) Inclusive Tapered Implant System (K121406) Shofu MonoCem Resin Cement (K020481)… | 2013 |
| † | K020481 | Pulpdent Post Cement | 2002 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191222 | Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant… | 2019 | 4 |
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 22 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 8 of the 94 ancestors have a recall of any class.
- Of its descendants, K191222 (Prismatik Dentalcraft, Inc., 2019) has gone furthest, with 4 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. 2017, 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 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.
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.
Compatible Implant System: MegaGen AnyRidge® Implant System
Implant Diameter (mm) 3.5, 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9, 7.4, 7.9, 8.4
Platform Diameter (mm) 3.5 and 5.0
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170044 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170044: Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170044
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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