510(k) · Cleared
ClearedRescue 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 Apr 19, 2006 as substantially equivalent to K010185 (Bicon, Inc., 2002) and 1 other predicate after a 138-day review. Its family tree reaches back 1 generation to 2002. 118 later devices descend from it.
- Decided
- Apr 19, 2006
- Review
- 138 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K010185 (2002). 2 ancestors in all. 118 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK010185 6.0 X 5.7MM Dental ImplantBicon, Inc. · 2002
- This deviceK053353 Rescue Implant SystemMegagen Co., Ltd. · 2006
- Descendant · cites it directly · 112 of its ownK063216 Rescue Internal Implant SystemMegagen Co., Ltd. · 2007
- Descendant · 2 generations on · 96 of its ownK073058 Rescue Internal Implant SystemMegagen Co., Ltd. · 2008
- Descendant · 3 generations on · 55 of its ownK090825 SQ IS SystemNeobiotech Co., Ltd. · 2009
- Descendant · 3 generations on · 43 of its ownK110955 Anyridge Internal Implant SystemMegagen Co., Ltd. · 2011
- Descendant · 4 generations on · 34 of its ownK113554 Cmi Implant IS SystemNeobiotech Co., Ltd. · 2012
Showing 5 of 118 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 118 · See all- K063216Rescue Internal Implant SystemMegagen Co., Ltd. · 2007 · cites it directly112descendants
- K073058Rescue Internal Implant SystemMegagen Co., Ltd. · 2008 · 2 generations on96descendants
- K090825SQ IS SystemNeobiotech Co., Ltd. · 2009 · 3 generations on55descendants
- K110955Anyridge Internal Implant SystemMegagen Co., Ltd. · 2011 · 3 generations on43descendants
- K113554Cmi Implant IS SystemNeobiotech Co., Ltd. · 2012 · 4 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010185 | 6.0 X 5.7MM Dental Implant | Bicon, Inc. | 2002 | — |
| 0 (this device) | K053353 | Rescue Implant System | Megagen Co., Ltd. | 2006 | — |
| +1 | K063216 | Rescue Internal Implant System | Megagen Co., Ltd. | 2007 | — |
| +2 | K073058 | Rescue Internal Implant System | Megagen Co., Ltd. | 2008 | — |
| +3 | K090825 | SQ IS System | Neobiotech Co., Ltd. | 2009 | — |
| +3 | K110955 | Anyridge Internal Implant System | Megagen Co., Ltd. | 2011 | — |
| +4 | K113554 | Cmi Implant IS System | Neobiotech Co., Ltd. | 2012 | — |
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 |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 6 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 7 | 0 |
| 2019 | 6 | 0 |
| 2020 | 12 | 0 |
| 2021 | 11 | 0 |
| 2022 | 11 | 0 |
| 2023 | 15 | 0 |
| 2024 | 12 | 0 |
| 2025 | 10 | 0 |
| 2026 | 4 | 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? (2)
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 |
|---|---|---|---|
| * | K010185 | 6.0 X 5.7MM Dental ImplantSummary page 3…, and BICON Implant Rescue Dental Implant BICON Dental Implant System Systems K010185, K050712 Manufacturer MegaGen Co., Ltd. BICON Dental Implants Mandibl… | 2002 |
| * | K050712 | 4.5.* 6.0MM Dental Implant and 6.0*6.0 MM Dental ImplantSummary page 1…es panel 21 CFR ~ 872.3640 Regulation Number: 872.3640 13-7. Predicate Devices BICON Implant Systems (K01085, K050712) 13-8. Performance Laboratory testing was conducted to determine device functionality and… | 2005 |
What descends from it? (118)
See all 1184 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?
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 Rescue® 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/K053353 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053353: Rescue Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053353
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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