# K192347: ST Internal Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Megagen Implant Co., Ltd.
- Decided: Nov 14, 2019 after 77 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: 13 generations back to K960026 (1996). 106 ancestors in all.
No later device cites it as a predicate yet.
0 of 107 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182448: AnyRidge Octa 1 Implant System, Megagen Implant Co., Ltd. (2019). Cleared while this submission was under review Summary page 4.

## Indications for use
The ST Internal Implant System is intended to be surgically placed in the maxillary or mandibular arches 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/K192347
Methodology: https://510kreport.com/methodology