# K182448: AnyRidge Octa 1 Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Megagen Implant Co., Ltd.
- Decided: Oct 9, 2019 after 397 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: 12 generations back to K960026 (1996). 105 ancestors in all.
9 later devices descend from it; 7 cite it directly.
0 of 115 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.
- K110955: Anyridge Internal Implant System, Megagen Co., Ltd. (2011) Summary page 5.
- K072570: Nobelactive Multi Unit Abutment, Nobel Biocare AB (2007) Summary page 5.
- K123988: Anyonetm Internal Implant System, Megagen Implant Co., Ltd. (2013) Summary page 5.
- K161244: s-Clean OneQ-SL Narrow Implant System, Dentis Co., Ltd. (2016) Summary page 15.

## Most influential descendants
- K203240: AccelX Abutments (2021), 2 descendants of its own
- K252585: ZENEX Implant System_R-System (2026), 1 descendant of its own
- K253334: ZENEX Implant System_Short (R-System) (2026), 0 descendants of its own
- K240383: Highness Implant System (2024), 0 descendants of its own
- K231100: Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw (2024), 0 descendants of its own

## Indications for use
The AnyRidge Octa 1 Implant System 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 implants are dedicated for the molar region.

Source page: https://510kreport.com/device/K182448
Methodology: https://510kreport.com/methodology
