510(k) · Cleared
ClearedExfeel Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Megagen Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Jan 10, 2006 as substantially equivalent to K041655 (Cowellmedi Co., Ltd., 2004) and 6 other predicates after a 134-day review. Its family tree reaches back 6 generations to 1995. 84 later devices descend from it.
- Decided
- Jan 10, 2006
- Review
- 134 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 6 generations to K944964 (1995). 53 ancestors in all, the oldest K874590 (1988). 84 later devices descend from it, 6 citing it directly.
- Root · 6 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 5 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 4 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 3 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 2 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 1 generation backK041655 Bio Plant System (Implants and Abutments)Cowellmedi Co., Ltd. · 2004
- This deviceK052369 Exfeel Implant SystemMegagen Co., Ltd. · 2006
- Descendant · cites it directly · 74 of its ownK070562 EZ Plus Implant SystemMegagen Co., Ltd. · 2007
- Descendant · 2 generations on · 43 of its ownK110955 Anyridge Internal Implant SystemMegagen Co., Ltd. · 2011
- Descendant · 3 generations on · 25 of its ownK122231 Xpeed Any Ridge Internal Implant SystemMegagen Implant Co., Ltd. · 2012
- Descendant · 2 generations on · 25 of its ownK073486 Dentis Dental Implant SystemDentis Co., Ltd. · 2008
- Descendant · 3 generations on · 20 of its ownK150344 Dentis Dental Implant SystemDentis Co., Ltd. · 2015
Showing 5 of 84 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 84 · See all- K070562EZ Plus Implant SystemMegagen Co., Ltd. · 2007 · cites it directly74descendants
- K110955Anyridge Internal Implant SystemMegagen Co., Ltd. · 2011 · 2 generations on43descendants
- K122231Xpeed Any Ridge Internal Implant SystemMegagen Implant Co., Ltd. · 2012 · 3 generations on25descendants
- K073486Dentis Dental Implant SystemDentis Co., Ltd. · 2008 · 2 generations on25descendants
- K150344Dentis Dental Implant SystemDentis Co., Ltd. · 2015 · 3 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −5 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −4 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −3 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −2 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −1 | K041655 | Bio Plant System (Implants and Abutments) | Cowellmedi Co., Ltd. | 2004 | — |
| 0 (this device) | K052369 | Exfeel Implant System | Megagen Co., Ltd. | 2006 | — |
| +1 | K070562 | EZ Plus Implant System | Megagen Co., Ltd. | 2007 | — |
| +2 | K110955 | Anyridge Internal Implant System | Megagen Co., Ltd. | 2011 | — |
| +3 | K122231 | Xpeed Any Ridge Internal Implant System | Megagen Implant Co., Ltd. | 2012 | — |
| +2 | K073486 | Dentis Dental Implant System | Dentis Co., Ltd. | 2008 | — |
| +3 | K150344 | Dentis Dental Implant System | Dentis Co., Ltd. | 2015 | — |
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 | 5 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 5 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 6 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 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? (7)
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 |
|---|---|---|---|
| * | K041655 | Bio Plant System (Implants and Abutments)Summary page 1…panel 21 CFR .~872.3640 Regulation Number: 872 3640 13-7 Predicate Devices BIOPLANT Implant Systems (K041655) & Branemark Systems (K925777, K925779, K961728, K971706) 13-8. Performance Laboratory… | 2004 |
| * | K925777 | Branemark System Estheticone Abutment CompleteSummary page 1…Regulation Number: 872 3640 13-7 Predicate Devices BIOPLANT Implant Systems (K041655) & Branemark Systems (K925777, K925779, K961728, K971706) 13-8. Performance Laboratory testing was conducted to determine device functionality… | 1993 |
| * | K925779 | Branemark System Titanium Healing AbutmentsSummary page 1…Regulation Number: 872 3640 13-7 Predicate Devices BIOPLANT Implant Systems (K041655) & Branemark Systems (K925777, K925779, K961728, K971706) 13-8. Performance Laboratory testing was conducted to determine device functionality… | 1993 |
| * | K961728 | Miruscone Abutment SystemSummary page 1…Regulation Number: 872 3640 13-7 Predicate Devices BIOPLANT Implant Systems (K041655) & Branemark Systems (K925777, K925779, K961728, K971706) 13-8. Performance Laboratory testing was conducted to determine device functionality… | 1996 |
| * | K971706 | Tiadapt Abutment SystemSummary page 1…egulation Number: 872 3640 13-7 Predicate Devices BIOPLANT Implant Systems (K041655) & Branemark Systems (K925777, K925779, K961728, K971706) 13-8. Performance Laboratory testing was conducted to determine device functionality a… | 1997 |
| * | K002374 | Iti Dental Implant System Monotype ImplantSummary page 2…rgical procedure or a single stage surgical procedure I13-12.' Bas's for Substantial Equivalence The Exfeel Implants are substantially to ITI Dental Implant(K002374), Nobel Biocare Branemark Dental lmplant(K993595) in intended use, material and design. The Exfeel Implants are compose… | 2000 |
| * | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon Placement)Summary page 2…edure I13-12.' Bas's for Substantial Equivalence The Exfeel Implants are substantially to ITI Dental Implant(K002374), Nobel Biocare Branemark Dental lmplant(K993595) in intended use, material and design. The Exfeel Implants are composed of the same material and have the same surface as th… | 2000 |
What descends from it? (84)
See all 846 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 11 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 53 ancestors have a recall of any class.
- Of its descendants, K070562 (Megagen Co., Ltd., 2007) has gone furthest, with 74 descendants of its own.
- 1 other device also cites its predicate K041655.
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?
The ExFeel Dental Implant Systems are intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052369 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052369: Exfeel Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052369
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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