510(k) · Cleared
ClearedAccelX Abutments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integrated Dental Systems, LLC · NHA Abutment, Implant, Dental, Endosseous
Cleared on Apr 27, 2021 as substantially equivalent to K191986 (Terrats Medical SL, 2019) and 4 other predicates after a 175-day review. Its family tree reaches back 18 generations to 1996. 2 later devices descend from it.
- Decided
- Apr 27, 2021
- Review
- 175 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 18 generations to K960026 (1996). 369 ancestors in all, the oldest K781060 (1978). 2 later devices descend from it, 1 citing it directly.
- Root · 18 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 14 generations between
- 3 generations backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- 2 generations backK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- 1 generation backK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
- This deviceK203240 AccelX AbutmentsIntegrated Dental Systems, LLC · 2021
- Descendant · cites it directly · 1 of its ownK252585 ZENEX Implant System_R-SystemIzenimplant Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK253334 ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd. · 2026
Show all 18 generations
- Root · 18 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 17 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 16 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 15 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 14 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 13 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 12 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 11 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 10 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 9 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 8 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 7 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 6 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 5 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- 4 generations backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 3 generations backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- 2 generations backK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- 1 generation backK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
- This deviceK203240 AccelX AbutmentsIntegrated Dental Systems, LLC · 2021
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 |
|---|---|---|---|---|---|
| −18 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −17 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −16 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −15 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −14 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −13 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −12 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −11 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −10 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −9 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −8 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −7 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| −6 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| −5 | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart… | Neodent USA, Inc. | 2014 | — |
| −4 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| −3 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| −2 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
| −1 | K191986 | DESS Dental Smart Solutions | Terrats Medical SL | 2019 | — |
| 0 (this device) | K203240 | AccelX Abutments | Integrated Dental Systems, LLC | 2021 | — |
| +1 | K252585 | ZENEX Implant System_R-System | Izenimplant Co., Ltd. | 2026 | — |
| +2 | K253334 | ZENEX Implant System_Short (R-System) | Izenimplant Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 7 | 0 |
| 1991 | 3 | 0 |
| 1992 | 5 | 0 |
| 1993 | 14 | 0 |
| 1994 | 14 | 0 |
| 1995 | 15 | 0 |
| 1996 | 17 | 0 |
| 1997 | 7 | 0 |
| 1998 | 8 | 0 |
| 1999 | 12 | 0 |
| 2000 | 11 | 0 |
| 2001 | 18 | 0 |
| 2002 | 19 | 0 |
| 2003 | 18 | 0 |
| 2004 | 20 | 0 |
| 2005 | 16 | 0 |
| 2006 | 22 | 0 |
| 2007 | 28 | 0 |
| 2008 | 20 | 0 |
| 2009 | 15 | 0 |
| 2010 | 12 | 0 |
| 2011 | 14 | 0 |
| 2012 | 8 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 30.6 · 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 |
|---|---|---|---|
| * | K191986 | DESS Dental Smart SolutionsSummary page 4…ENT and Dental Devices) Reviewing Division Division of Health Technology 1 B (Dental Devices) PREDICATE DEVICE INFORMATION Primary Predicate Device K191986, DESS Dental Smart Solutions, Terrats Medical SL Additional Predicate Devices K123988, AnyOne™ Internal Implant System, MegaGen I… | 2019 |
| * | K123988 | Anyonetm Internal Implant SystemSummary page 4…hnology 1 B (Dental Devices) PREDICATE DEVICE INFORMATION Primary Predicate Device K191986, DESS Dental Smart Solutions, Terrats Medical SL Additional Predicate Devices K123988, AnyOne™ Internal Implant System, MegaGen Implant Company, Limited K182448, AnyRidge Octa 1 Implant System, MegaGen Implant Co.,… | 2013 |
| * | K182448 | AnyRidge Octa 1 Implant SystemSummary page 4…e Device K191986, DESS Dental Smart Solutions, Terrats Medical SL Additional Predicate Devices K123988, AnyOne™ Internal Implant System, MegaGen Implant Company, Limited K182448, AnyRidge Octa 1 Implant System, MegaGen Implant Co., Ltd. K140091, Xpeed AnyRidge Internal Implant System, MegaGen Implant Co.,… | 2019 |
| * | K140091 | Xpeed Anyridge Internal Implant SysyemSummary page 4…dditional Predicate Devices K123988, AnyOne™ Internal Implant System, MegaGen Implant Company, Limited K182448, AnyRidge Octa 1 Implant System, MegaGen Implant Co., Ltd. K140091, Xpeed AnyRidge Internal Implant System, MegaGen Implant Co., Ltd. K140728, Dental Implants and Abutments, Ditron Precision Ltd.… | 2014 |
| * | K140728 | Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Summary page 4…en Implant Company, Limited K182448, AnyRidge Octa 1 Implant System, MegaGen Implant Co., Ltd. K140091, Xpeed AnyRidge Internal Implant System, MegaGen Implant Co., Ltd. K140728, Dental Implants and Abutments, Ditron Precision Ltd. 510(k) Summary… | 2014 |
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 |
|---|---|---|---|
| K252585 | ZENEX Implant System_R-System | 2026 | 1 |
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 25 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 49 of the 369 ancestors have a recall of any class.
- Of its descendants, K252585 (Izenimplant Co., Ltd., 2026) has gone furthest, with 1 descendant of its own.
- 8 other devices also cite its predicate K191986.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
AccelX™ Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations. All digitally designed abutments for use with AccelX™ CAD-CAM Abutments are intended to be sent to an Integrated Dental Systems validated milling center for manufacture. AccelX™ Abutments are compatible with MegaGen AnyRidge Internal Implant System components…
Read the full statement (103 words)
AccelX™ Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.
All digitally designed abutments for use with AccelX™ CAD-CAM Abutments are intended to be sent to an Integrated Dental Systems validated milling center for manufacture.
AccelX™ Abutments are compatible with MegaGen AnyRidge Internal Implant System components as listed below.
Implant System Compatibility - Implant Body Diameter, mm Implant Platform, mm
MegaGen AnyRidge Internal 4.0 3.5
Implant System 4.4 3.5
4.9 3.5
5.4 3.5
5.9 3.5
6.4 5.0
6.9 5.0
7.4 5.0
7.9 5.0
8.4 5.0
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203240 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203240: AccelX Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203240
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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