# K223339: Bone Chamber Implant

- Pathway: 510(k) (Traditional)
- Applicant: Megagen Implant Co., Ltd.
- Decided: Jul 18, 2023 after 259 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) Summary page 4.
- K063216: Rescue Internal Implant System, Megagen Co., Ltd. (2007) Summary page 4.

## Indications for use
Smaller Implant (Widest Thread Diameter: @4.0mm ~@5.0mm) The smaller Implant is intended to be surgically placed in the maxillary or mandibular arches for the purpose of 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 in the following situations and with the clinical protocols: - Delayed loading - Immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger Implant (Widest Thread Diameter: ©@5.6mm ~@7.0mm) The larger Implant is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants can be used where smaller implants have failed. It is used to restore a patient’s chewing function in the following situations and with the clinical protocols: - Delayed loading

Source page: https://510kreport.com/device/K223339
Methodology: https://510kreport.com/methodology