510(k) · Cleared
ClearedAtlas Implant System- Mini 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 Apr 20, 2009 as substantially equivalent to K051018 (Megagen Co., Ltd., 2005) and 2 other predicates after a 103-day review. Its family tree reaches back 9 generations to 1996.
- Decided
- Apr 20, 2009
- Review
- 103 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K960026 (1996). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 5 generations between
- 3 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 2 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 1 generation backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- This deviceK090049 Atlas Implant System- Mini PlusCowellmedi Co., Ltd. · 2009
Show all 9 generations
- Root · 9 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 8 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 7 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 6 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 5 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 4 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 3 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 2 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 1 generation backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- This deviceK090049 Atlas Implant System- Mini PlusCowellmedi Co., Ltd. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −8 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −7 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −6 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −5 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −4 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −3 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −2 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −1 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| 0 (this device) | K090049 | Atlas Implant System- Mini Plus | Cowellmedi Co., Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K051018 | Intermezzo Implant SystemsSummary page 2…wing ASTM and ISO standards. Predicate Devices The subject device is substantially equivalent to the following predicate devices: * litermezzoTM Implant System (K051018) manufactured by Megagen Implant Co., Ltd. * IMTEC Sendax MDI and MDI Plus (K031106) manufactured by IMTEC Corporation. *… | 2005 |
| * | K031106 | Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XXSummary page 2…quivalent to the following predicate devices: * litermezzoTM Implant System (K051018) manufactured by Megagen Implant Co., Ltd. * IMTEC Sendax MDI and MDI Plus (K031106) manufactured by IMTEC Corporation. * MaximusTM OS Implant (K041938) manufactured by BioHorizons Implant Systems, Inc. Com… | 2003 |
| * | K041938 | Maximus OS (Overdenture System)Summary page 2…t System (K051018) manufactured by Megagen Implant Co., Ltd. * IMTEC Sendax MDI and MDI Plus (K031106) manufactured by IMTEC Corporation. * MaximusTM OS Implant (K041938) manufactured by BioHorizons Implant Systems, Inc. Comparison to Predicate Devices Testing and other comparisons have establi… | 2004 |
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 13 years and passes through 2 companies; a new generation was cleared every 8 months on median.
- 3 of the 17 ancestors have a recall of any class.
- 5 other devices also cite its predicate K051018.
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 - Mini Plus is intended to load immediately in partially or fully edentulous
manidibles and maxillae to serve as temporary support for provisional prosthetic device during the
healing phase of permanent endosseous dental implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090049 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090049: Atlas Implant System- Mini Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090049
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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