# K052254: Mytis Arrow XXXX

- Pathway: 510(k) (Traditional)
- Applicant: Brainbase Corporation
- Decided: Jun 1, 2006 after 287 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: 4 generations back to K925765 (1993). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022562: Various Branemark System Implants-Immediate Function Indication, Nobel Biocare AB (2002) Summary page 1.
- K993595: Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon Placement), Nobel Biocare Uas, Inc. (2000) Summary page 1.
- K022113: 3I Dental Implant Accessories, Implant Innovations, Inc. (2002) Summary page 1.
- K022009: 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants, Implant Innovations, Inc. (2002) Summary page 1.

## Indications for use
Mytis Arrow XXXX systems are intended for immediate placement in extraction or surgically prepared sites in partially or fully edentulous mandibles and maxillae (type I or I1 bone), in support of single or multiple-unit restorations including; cement retained, screw retained, or over-denture restorations, and terminal or intermediate abutment support for fixed bridgework.

Source page: https://510kreport.com/device/K052254
Methodology: https://510kreport.com/methodology