# K081302: Rescue External Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Megagen Implant Co., Ltd.
- Decided: Aug 15, 2008 after 99 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K010185 (2002). 5 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063216: Rescue Internal Implant System, Megagen Co., Ltd. (2007) Summary page 2.
- K053353: Rescue Implant System, Megagen Co., Ltd. (2006) Summary page 2.
- K073058: Rescue Internal Implant System, Megagen Co., Ltd. (2008) Summary page 2.

## Most influential descendants
- K110337: Universal Maxillary Molar (2012), 1 descendant of its own
- K090054: Atlas Implant System - Wide Plus (2009), 1 descendant of its own
- K122198: 6.00MM X 6.00MM Macro External Implant System (2013), 0 descendants of its own
- K090377: Sinus Quick EB System (2009), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K081302
Methodology: https://510kreport.com/methodology