510(k) · Cleared
ClearedRescue Internal 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 2, 2007 as substantially equivalent to K053353 (Megagen Co., Ltd., 2006) after a 160-day review. Its family tree reaches back 2 generations to 2002. 112 later devices descend from it.
- Decided
- Apr 2, 2007
- Review
- 160 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010185 (2002). 3 ancestors in all. 112 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK010185 6.0 X 5.7MM Dental ImplantBicon, Inc. · 2002
- 1 generation backK053353 Rescue Implant SystemMegagen Co., Ltd. · 2006
- This deviceK063216 Rescue Internal Implant SystemMegagen Co., Ltd. · 2007
- Descendant · cites it directly · 96 of its ownK073058 Rescue Internal Implant SystemMegagen Co., Ltd. · 2008
- Descendant · 2 generations on · 55 of its ownK090825 SQ IS SystemNeobiotech Co., Ltd. · 2009
- Descendant · 2 generations on · 43 of its ownK110955 Anyridge Internal Implant SystemMegagen Co., Ltd. · 2011
- Descendant · 3 generations on · 34 of its ownK113554 Cmi Implant IS SystemNeobiotech Co., Ltd. · 2012
- Descendant · 3 generations on · 25 of its ownK122231 Xpeed Any Ridge Internal Implant SystemMegagen Implant Co., Ltd. · 2012
Showing 5 of 112 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 112 · See all- K073058Rescue Internal Implant SystemMegagen Co., Ltd. · 2008 · cites it directly96descendants
- K090825SQ IS SystemNeobiotech Co., Ltd. · 2009 · 2 generations on55descendants
- K110955Anyridge Internal Implant SystemMegagen Co., Ltd. · 2011 · 2 generations on43descendants
- K113554Cmi Implant IS SystemNeobiotech Co., Ltd. · 2012 · 3 generations on34descendants
- K122231Xpeed Any Ridge Internal Implant SystemMegagen Implant Co., Ltd. · 2012 · 3 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010185 | 6.0 X 5.7MM Dental Implant | Bicon, Inc. | 2002 | — |
| −1 | K053353 | Rescue Implant System | Megagen Co., Ltd. | 2006 | — |
| 0 (this device) | K063216 | Rescue Internal Implant System | Megagen Co., Ltd. | 2007 | — |
| +1 | K073058 | Rescue Internal Implant System | Megagen Co., Ltd. | 2008 | — |
| +2 | K090825 | SQ IS System | Neobiotech Co., Ltd. | 2009 | — |
| +2 | K110955 | Anyridge Internal Implant System | Megagen Co., Ltd. | 2011 | — |
| +3 | K113554 | Cmi Implant IS System | Neobiotech Co., Ltd. | 2012 | — |
| +3 | K122231 | Xpeed Any Ridge Internal Implant System | Megagen Implant 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 |
|---|---|---|
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 5 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 6 | 0 |
| 2019 | 5 | 0 |
| 2020 | 11 | 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? (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 |
|---|---|---|---|
| * | K053353 | Rescue Implant SystemSummary page 2…0 and 21 CFR 872.3630. 11. Substantial Equivalence Comparison: Rescue Internal Implant System is essentially an addition to the Rescue External Implant System (K053353). The noted difference in the design and material does not effectively change the performance of the device.… | 2006 |
What descends from it? (112)
See all 1126 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 5 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K073058 (Megagen Co., Ltd., 2008) has gone furthest, with 96 descendants of its own.
- 3 other devices also cite its predicate K053353.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Internal 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/K063216 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063216: Rescue Internal 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/K063216
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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