# K203554: AnyOne External Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Megagen Implant Co., Ltd.
- Decided: Aug 28, 2021 after 267 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: 10 generations back to K944964 (1995). 71 ancestors in all.
No later device cites it as a predicate yet.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122231: Xpeed Any Ridge Internal Implant System, Megagen Implant Co., Ltd. (2012) Summary page 4.

## Indications for use
The AnyOne 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. It is used to restore a patient's chewing function. Smaller implants (less than 6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.

Source page: https://510kreport.com/device/K203554
Methodology: https://510kreport.com/methodology