510(k) · Cleared
ClearedAccelx Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotech Dental, LLC · DZE Implant, Endosseous, Root-Form
Cleared on Nov 6, 2024 as substantially equivalent to K123870 (Megagen Implant Co., Ltd., 2013) after a 98-day review. Its family tree reaches back 11 generations to 1995.
- Decided
- Nov 6, 2024
- Review
- 98 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K944964 (1995). 72 ancestors in all, the oldest K874590 (1988). 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 backK110955 Anyridge Internal Implant SystemMegagen Co., Ltd. · 2011
- 2 generations backK122231 Xpeed Any Ridge Internal Implant SystemMegagen Implant Co., Ltd. · 2012
- 1 generation backK123870 Xpeed Anyridge Internal Implant SystemMegagen Implant Co., Ltd. · 2013
- This deviceK242261 Accelx Implant SystemBiotech Dental, LLC · 2024
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 backK041655 Bio Plant System (Implants and Abutments)Cowellmedi Co., Ltd. · 2004
- 5 generations backK052369 Exfeel Implant SystemMegagen Co., Ltd. · 2006
- 4 generations backK070562 EZ Plus Implant SystemMegagen Co., Ltd. · 2007
- 3 generations backK110955 Anyridge Internal Implant SystemMegagen Co., Ltd. · 2011
- 2 generations backK122231 Xpeed Any Ridge Internal Implant SystemMegagen Implant Co., Ltd. · 2012
- 1 generation backK123870 Xpeed Anyridge Internal Implant SystemMegagen Implant Co., Ltd. · 2013
- This deviceK242261 Accelx Implant SystemBiotech Dental, LLC · 2024
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 | K041655 | Bio Plant System (Implants and Abutments) | Cowellmedi Co., Ltd. | 2004 | — |
| −5 | K052369 | Exfeel Implant System | Megagen Co., Ltd. | 2006 | — |
| −4 | K070562 | EZ Plus Implant System | Megagen Co., Ltd. | 2007 | — |
| −3 | K110955 | Anyridge Internal Implant System | Megagen Co., Ltd. | 2011 | — |
| −2 | K122231 | Xpeed Any Ridge Internal Implant System | Megagen Implant Co., Ltd. | 2012 | — |
| −1 | K123870 | Xpeed Anyridge Internal Implant System | Megagen Implant Co., Ltd. | 2013 | — |
| 0 (this device) | K242261 | Accelx Implant System | Biotech Dental, LLC | 2024 | — |
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 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 7 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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 DZE? 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 DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 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 |
|---|---|---|---|
| * | K123870 | Xpeed Anyridge Internal Implant SystemSummary page 6…l characteristics with the following Reference devices. 510(k) Predicate Device Name Company Name K123870 Xpeed AnyRidge Internal Implant System MegaGen Implant Co., Ltd. 510(k)… | 2013 |
| † | K203240 | AccelX Abutments | 2021 |
| † | K233231 | Dental Implants and Abutments | 2024 |
| † | K110955 | Anyridge Internal Implant System | 2011 |
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 29 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 6 of the 72 ancestors have a recall of any class.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, 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 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
Accelx Implant System implants are indicated for use in partially or fully edentulous patients to support maxillary and mandibular single-unit, multiple-unit, and overdenture dental restorations. Accelx Implant System implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implant diameters larger than 6.0 mm are dedicated for the molar region and are indicated for delayed loading.…
Read the full statement (109 words)
Accelx Implant System implants are indicated for use in partially or fully edentulous patients to support maxillary and mandibular single-unit, multiple-unit, and overdenture dental restorations. Accelx Implant System implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implant diameters larger than 6.0 mm are dedicated for the molar region and are indicated for delayed loading.
Accelx Implant System implants are compatible with Accelx Implant System abutments.
Accelx Implant System implants are compatible with MegaGen AnyRidge Internal Implant System titanium abutments as listed below.
Accelx Implant System cover screws are compatible with MegaGen AnyRidge Internal Implant System implant components as listed below.
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/K242261 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242261: Accelx 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/K242261
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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