510(k) · Cleared
ClearedRescue External Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Megagen Implant Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Aug 15, 2008 as substantially equivalent to K063216 (Megagen Co., Ltd., 2007) and 2 other predicates after a 99-day review. Its family tree reaches back 4 generations to 2002. 4 later devices descend from it.
- Decided
- Aug 15, 2008
- Review
- 99 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K010185 (2002). 5 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK010185 6.0 X 5.7MM Dental ImplantBicon, Inc. · 2002
- 3 generations backK053353 Rescue Implant SystemMegagen Co., Ltd. · 2006
- 2 generations backK063216 Rescue Internal Implant SystemMegagen Co., Ltd. · 2007
- 1 generation backK073058 Rescue Internal Implant SystemMegagen Co., Ltd. · 2008
- This deviceK081302 Rescue External Implant SystemMegagen Implant Co., Ltd. · 2008
- Descendant · cites it directly · 1 of its ownK110337 Universal Maxillary MolarOco Biomedical · 2012
- Descendant · cites it directly · 1 of its ownK090054 Atlas Implant System - Wide PlusCowellmedi Co., Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK122198 6.00MM X 6.00MM Macro External Implant SystemOco Biomedical · 2013
- Descendant · 2 generations on · 0 of its ownK090377 Sinus Quick EB SystemNeobiotech Co., Ltd. · 2009
Most influential descendants
Showing 4 of 4 · See all- K110337Universal Maxillary MolarOco Biomedical · 2012 · cites it directly1descendant
- K090054Atlas Implant System - Wide PlusCowellmedi Co., Ltd. · 2009 · cites it directly1descendant
- K1221986.00MM X 6.00MM Macro External Implant SystemOco Biomedical · 2013 · cites it directly0descendants
- K090377Sinus Quick EB SystemNeobiotech Co., Ltd. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010185 | 6.0 X 5.7MM Dental Implant | Bicon, Inc. | 2002 | — |
| −3 | K053353 | Rescue Implant System | Megagen Co., Ltd. | 2006 | — |
| −2 | K063216 | Rescue Internal Implant System | Megagen Co., Ltd. | 2007 | — |
| −1 | K073058 | Rescue Internal Implant System | Megagen Co., Ltd. | 2008 | — |
| 0 (this device) | K081302 | Rescue External Implant System | Megagen Implant Co., Ltd. | 2008 | — |
| +1 | K110337 | Universal Maxillary Molar | Oco Biomedical | 2012 | — |
| +1 | K090054 | Atlas Implant System - Wide Plus | Cowellmedi Co., Ltd. | 2009 | — |
| +1 | K122198 | 6.00MM X 6.00MM Macro External Implant System | Oco Biomedical | 2013 | — |
| +2 | K090377 | Sinus Quick EB System | Neobiotech Co., Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K063216 | Rescue Internal Implant SystemSummary page 2…arison: Rescue External Implant System is essentially an addition to the predicate device previously cleared for marketing by FDA, Rescue Dental Implant System (K063216, K053353) and Rescue Internal Implant System (K073058). The noted difference in the design and material does not effective… | 2007 |
| * | K053353 | Rescue Implant SystemSummary page 2…Rescue External Implant System is essentially an addition to the predicate device previously cleared for marketing by FDA, Rescue Dental Implant System (K063216, K053353) and Rescue Internal Implant System (K073058). The noted difference in the design and material does not effectively change… | 2006 |
| * | K073058 | Rescue Internal Implant SystemSummary page 2…entially an addition to the predicate device previously cleared for marketing by FDA, Rescue Dental Implant System (K063216, K053353) and Rescue Internal Implant System (K073058). The noted difference in the design and material does not effectively change the performance of the device and Rescue Ext… | 2008 |
What descends from it? (4)
3 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 6 years and passes through 3 companies; a new generation was cleared every 1.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K110337 (Oco Biomedical, 2012) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K063216.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Rescue External Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants are intended to be used where smaller implants have failed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081302 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081302: Rescue External 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/K081302
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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