510(k) · Cleared
ClearedAtlas Implant System - Wide Plus
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 Jul 29, 2009 as substantially equivalent to K071148 (Cowellmedi Co., Ltd., 2008) and 2 other predicates after a 202-day review. Its family tree reaches back 8 generations to 1995. 1 later device descends from it.
- Decided
- Jul 29, 2009
- Review
- 202 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K944964 (1995). 69 ancestors in all, the oldest K874590 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 7 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 6 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 5 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 4 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 3 generations backK041655 Bio Plant System (Implants and Abutments)Cowellmedi Co., Ltd. · 2004
- 2 generations backK050635 Allfim Implant SystemsCowellmedi Co., Ltd. · 2005
- 1 generation backK071148 Atlas Implant SystemCowellmedi Co., Ltd. · 2008
- This deviceK090054 Atlas Implant System - Wide PlusCowellmedi Co., Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK090377 Sinus Quick EB SystemNeobiotech Co., Ltd. · 2009
Most influential descendants
Showing 1 of 1 · See all- K090377Sinus Quick EB SystemNeobiotech Co., Ltd. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −7 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −6 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −5 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −4 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −3 | K041655 | Bio Plant System (Implants and Abutments) | Cowellmedi Co., Ltd. | 2004 | — |
| −2 | K050635 | Allfim Implant Systems | Cowellmedi Co., Ltd. | 2005 | — |
| −1 | K071148 | Atlas Implant System | Cowellmedi Co., Ltd. | 2008 | — |
| 0 (this device) | K090054 | Atlas Implant System - Wide Plus | Cowellmedi Co., Ltd. | 2009 | — |
| +1 | K090377 | Sinus Quick EB System | Neobiotech Co., Ltd. | 2009 | — |
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 | 6 | 0 |
| 2001 | 3 | 0 |
| 2002 | 6 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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? (3)
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 |
|---|---|---|---|
| * | K071148 | Atlas Implant SystemSummary page 2…following ASTM and ISO standards. Predicate Devices The subject device is substantially equivalent to the following predicate devices: * Atlas Implant System (K071148) manufactured by Cowellmedi Co., Ltd. · Rescue External Implant System (K081302) manufactured by Megagen Implant Co., Ltd.… | 2008 |
| * | K081302 | Rescue External Implant SystemSummary page 2…ially equivalent to the following predicate devices: * Atlas Implant System (K071148) manufactured by Cowellmedi Co., Ltd. · Rescue External Implant System (K081302) manufactured by Megagen Implant Co., Ltd. · US Ultra Wide System (K073465) manufactured by Osstem Co., Ltd. Comparison… | 2008 |
| * | K073465 | US/GS Ultra Wide SystemSummary page 2…m (K071148) manufactured by Cowellmedi Co., Ltd. · Rescue External Implant System (K081302) manufactured by Megagen Implant Co., Ltd. · US Ultra Wide System (K073465) manufactured by Osstem Co., Ltd. Comparison to Predicate Devices Testing and other comparisons have established that the sub… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090377 | Sinus Quick EB System | 2009 | 0 |
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 14 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 5 of the 69 ancestors have a recall of any class.
- Of its descendants, K090377 (Neobiotech Co., Ltd., 2009) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K071148.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
The Atlas Implant System - Wide Plus is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Also, there are no angled abutments intended to be used with this system. Smaller (o 4.5, e 5.5) implants are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger (e 6.0 to o 8.0) implants are dedicated for the molar region and not indicated for immediate loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090054 · printed Nov 5, 2026
Cite this page
510(k) Report. “K090054: Atlas Implant System - Wide Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K090054
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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