510(k) · Cleared
ClearedBio Plant System (Implants and Abutments)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cowellmedi Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Sep 8, 2004 as substantially equivalent to K925777 (Nobelpharma USA, Inc., 1993) and 13 other predicates after an 82-day review. Its family tree reaches back 5 generations to 1995. 91 later devices descend from it.
- Decided
- Sep 8, 2004
- Review
- 82 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 14
Its longest line of descent runs back 5 generations to K944964 (1995). 51 ancestors in all, the oldest K874590 (1988). 91 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 4 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 3 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 2 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 1 generation backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- This deviceK041655 Bio Plant System (Implants and Abutments)Cowellmedi Co., Ltd. · 2004
- Descendant · cites it directly · 84 of its ownK052369 Exfeel Implant SystemMegagen Co., Ltd. · 2006
- Descendant · 2 generations on · 74 of its ownK070562 EZ Plus Implant SystemMegagen Co., Ltd. · 2007
- Descendant · 3 generations on · 43 of its ownK110955 Anyridge Internal Implant SystemMegagen Co., Ltd. · 2011
- Descendant · 4 generations on · 25 of its ownK122231 Xpeed Any Ridge Internal Implant SystemMegagen Implant Co., Ltd. · 2012
- Descendant · 3 generations on · 25 of its ownK073486 Dentis Dental Implant SystemDentis Co., Ltd. · 2008
Showing 5 of 91 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 91 · See all- K052369Exfeel Implant SystemMegagen Co., Ltd. · 2006 · cites it directly84descendants
- K070562EZ Plus Implant SystemMegagen Co., Ltd. · 2007 · 2 generations on74descendants
- K110955Anyridge Internal Implant SystemMegagen Co., Ltd. · 2011 · 3 generations on43descendants
- K122231Xpeed Any Ridge Internal Implant SystemMegagen Implant Co., Ltd. · 2012 · 4 generations on25descendants
- K073486Dentis Dental Implant SystemDentis Co., Ltd. · 2008 · 3 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −4 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −3 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −2 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −1 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| 0 (this device) | K041655 | Bio Plant System (Implants and Abutments) | Cowellmedi Co., Ltd. | 2004 | — |
| +1 | K052369 | Exfeel Implant System | Megagen Co., Ltd. | 2006 | — |
| +2 | K070562 | EZ Plus Implant System | Megagen Co., Ltd. | 2007 | — |
| +3 | K110955 | Anyridge Internal Implant System | Megagen Co., Ltd. | 2011 | — |
| +4 | K122231 | Xpeed Any Ridge Internal Implant System | Megagen Implant Co., Ltd. | 2012 | — |
| +3 | K073486 | Dentis Dental Implant System | Dentis Co., Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 10 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 6 | 0 |
| 2017 | 5 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 6 | 0 |
| 2021 | 10 | 0 |
| 2022 | 7 | 0 |
| 2023 | 10 | 0 |
| 2024 | 7 | 0 |
| 2025 | 7 | 0 |
| 2026 | 5 | 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? (14)
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 |
|---|---|---|---|
| * | K925777 | Branemark System Estheticone Abutment CompleteSummary page 1…K971706, Devices: .Predicate Branemark System - Nobel Biocare: K925777, K925779, K961728, Systems - K993595, K022562 and 3i Restorative… | 1993 |
| * | K925779 | Branemark System Titanium Healing AbutmentsSummary page 1…K971706, Devices: .Predicate Branemark System - Nobel Biocare: K925777, K925779, K961728, Systems - K993595, K022562 and 3i Restorative Implant… | 1993 |
| * | K961728 | Miruscone Abutment SystemSummary page 1…K971706, Devices: .Predicate Branemark System - Nobel Biocare: K925777, K925779, K961728, Systems - K993595, K022562 and 3i Restorative Implant… | 1996 |
| * | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon Placement)Summary page 1….Predicate Branemark System - Nobel Biocare: K925777, K925779, K961728, Systems - K993595, K022562 and 3i Restorative Implant K974150 K992937,… | 2000 |
| * | K022562 | Various Branemark System Implants-Immediate Function IndicationSummary page 1…cate Branemark System - Nobel Biocare: K925777, K925779, K961728, Systems - K993595, K022562 and 3i Restorative Implant K974150 K992937,… | 2002 |
| * | K971706 | Tiadapt Abutment SystemSummary page 1…Endlosseous implants, surgical components, and prosthetic K971706, Devices: .Predicate Branemark System - Nobel Biocare: K925777, K925779, K961728, Sys… | 1997 |
| * | K974150 | Procera Preparable Abutment SystemSummary page 1…, K961728, Systems - K993595, K022562 and 3i Restorative Implant K974150 K992937, K022009,… | 1998 |
| * | K992937 | Dental ImplantSummary page 1…8, Systems - K993595, K022562 and 3i Restorative Implant K974150 K992937, K022009,… | 2000 |
| * | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsSummary page 1…ant K974150 K992937, K022009, Implant Innovations Inc.: K983347, K965077, K934126, K935544,… | 2002 |
| * | K983347 | Osseotite Dental ImplantsSummary page 1…K022009, Implant Innovations Inc.: K983347, K965077, K934126, K935544, K022 113… | 1999 |
| * | K965077 | Single Toot Abutment System (Sta or ST Abutment ) for Single Ooth Cement Retained…Summary page 1…K022009, Implant Innovations Inc.: K983347, K965077, K934126, K935544, K022 113… | 1997 |
| * | K934126 | One and Two Piece Temporary Healing,(Emergence Profile) AbutmentsSummary page 1…K022009, Implant Innovations Inc.: K983347, K965077, K934126, K935544, K022 113… | 1994 |
| * | K935544 | 3I Standard Threaded/Self-Tapping Threaded Implants ModificationSummary page 1…K022009, Implant Innovations Inc.: K983347, K965077, K934126, K935544, K022 113… | 1995 |
| * | K022113 | 3I Dental Implant AccessoriesSummary page 1…K022009, Implant Innovations Inc.: K983347, K965077, K934126, K935544, K022 113 of precision-mach… | 2002 |
What descends from it? (91)
See all 912 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 9 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 5 of the 51 ancestors have a recall of any class.
- Of its descendants, K052369 (Megagen Co., Ltd., 2006) has gone furthest, with 84 descendants of its own.
- 3 other devices also cite its predicate K925777.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
BioPlant Systems refer to sets of root form endosseous dental implants and compatible implant abutment systems. BioPlant Systems are designed for use in dental implant surgery and are intended to be used in a manor in which they (the implants) integrate with the bone (osseointegration). The BioPlant abutment systems include various abutments designed to enable the implant process from healing thru final restoration. Clinical studies have demonstrated…
Read the full statement (157 words)
BioPlant Systems refer to sets of root form endosseous dental implants and compatible implant abutment systems. BioPlant Systems are designed for use in dental implant surgery and are intended to be used in a manor in which they (the implants) integrate with the bone (osseointegration). The BioPlant abutment systems include various abutments designed to enable the implant process from healing thru final restoration. Clinical studies have demonstrated that, when surgically implanted under controlled conditions, a successfully osseointegrated implant will achieve a firm and direct connection between the living bone and surface of the titanium implant. BioPlant implants are for single or two-stage surgical procedures. BioPlant Systems are intended for immediate placement in partially or fully edentulous mandibles and maxillae (type I or II bone), in support of single or multiple-unit restorations including; cemented retained, screw retained, or over-denture restorations, and terminal or intermediate abutment support for fixed bridgework. Multiple tooth applications may be splinted with a bar.
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/K041655 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041655: Bio Plant System (Implants and Abutments).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041655
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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