510(k) · Cleared
ClearedEZ Plus Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Megagen Co., Ltd. · NHA Abutment, Implant, Dental, Endosseous
Cleared on May 18, 2007 as substantially equivalent to K052369 (Megagen Co., Ltd., 2006) after an 80-day review. Its family tree reaches back 7 generations to 1995. 74 later devices descend from it.
- Decided
- May 18, 2007
- Review
- 80 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K944964 (1995). 54 ancestors in all, the oldest K874590 (1988). 74 later devices descend from it, 6 citing it directly.
- Root · 7 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 6 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 5 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 4 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 3 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 2 generations backK041655 Bio Plant System (Implants and Abutments)Cowellmedi Co., Ltd. · 2004
- 1 generation backK052369 Exfeel Implant SystemMegagen Co., Ltd. · 2006
- This deviceK070562 EZ Plus Implant SystemMegagen Co., Ltd. · 2007
- Descendant · cites it directly · 43 of its ownK110955 Anyridge Internal Implant SystemMegagen Co., Ltd. · 2011
- Descendant · 2 generations on · 25 of its ownK122231 Xpeed Any Ridge Internal Implant SystemMegagen Implant Co., Ltd. · 2012
- Descendant · cites it directly · 25 of its ownK073486 Dentis Dental Implant SystemDentis Co., Ltd. · 2008
- Descendant · 2 generations on · 20 of its ownK150344 Dentis Dental Implant SystemDentis Co., Ltd. · 2015
- Descendant · 3 generations on · 19 of its ownK123988 Anyonetm Internal Implant SystemMegagen Implant Co., Ltd. · 2013
Showing 5 of 74 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 74 · See all- K110955Anyridge Internal Implant SystemMegagen Co., Ltd. · 2011 · cites it directly43descendants
- K122231Xpeed Any Ridge Internal Implant SystemMegagen Implant Co., Ltd. · 2012 · 2 generations on25descendants
- K073486Dentis Dental Implant SystemDentis Co., Ltd. · 2008 · cites it directly25descendants
- K150344Dentis Dental Implant SystemDentis Co., Ltd. · 2015 · 2 generations on20descendants
- K123988Anyonetm Internal Implant SystemMegagen Implant Co., Ltd. · 2013 · 3 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −6 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −5 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −4 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −3 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −2 | K041655 | Bio Plant System (Implants and Abutments) | Cowellmedi Co., Ltd. | 2004 | — |
| −1 | K052369 | Exfeel Implant System | Megagen Co., Ltd. | 2006 | — |
| 0 (this device) | K070562 | EZ Plus Implant System | Megagen Co., Ltd. | 2007 | — |
| +1 | K110955 | Anyridge Internal Implant System | Megagen Co., Ltd. | 2011 | — |
| +2 | K122231 | Xpeed Any Ridge Internal Implant System | Megagen Implant Co., Ltd. | 2012 | — |
| +1 | K073486 | Dentis Dental Implant System | Dentis Co., Ltd. | 2008 | — |
| +2 | K150344 | Dentis Dental Implant System | Dentis Co., Ltd. | 2015 | — |
| +3 | K123988 | Anyonetm Internal Implant System | Megagen Implant Co., Ltd. | 2013 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 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 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? (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 |
|---|---|---|---|
| * | K052369 | Exfeel Implant SystemSummary page 1…ices panel 21 CFR ~ 872.3640 Regulation Number: 872.3640 13-7. Predicate Devices EXFEEL IMPLANT SYSTEM(K052369) 13-8. Performance Laboratory testing was conducted to determine device functionality… | 2006 |
What descends from it? (74)
See all 746 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 12 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 54 ancestors have a recall of any class.
- Of its descendants, K110955 (Megagen Co., Ltd., 2011) has gone furthest, with 43 descendants of its own.
- 5 other devices also cite its predicate K052369.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
The EZ Plus Implant Systems are intended to be surgically 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. Large angle abutments (e.g. 250) on small diameter implants of the EZ Plus internal connection system are intended for the anterior region of the mouth and not intended for use in the posterior region of the mouth due to limited strength of the implant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070562 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070562: EZ Plus 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/K070562
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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