# K053353: Rescue Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Megagen Co., Ltd.
- Decided: Apr 19, 2006 after 138 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: 1 generation back to K010185 (2002). 2 ancestors in all.
118 later devices descend from it; 4 cite it directly.
0 of 121 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010185: 6.0 X 5.7MM Dental Implant, Bicon, Inc. (2002) Summary page 3.
- K050712: 4.5.* 6.0MM Dental Implant and 6.0*6.0 MM Dental Implant, Bicon, Inc. (2005) Summary page 1.

## Most influential descendants
- K063216: Rescue Internal Implant System (2007), 112 descendants of its own
- K073058: Rescue Internal Implant System (2008), 96 descendants of its own
- K090825: SQ IS System (2009), 55 descendants of its own
- K110955: Anyridge Internal Implant System (2011), 43 descendants of its own
- K113554: Cmi Implant IS System (2012), 34 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K053353
Methodology: https://510kreport.com/methodology