# K050970: Milo Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Intra-Lock International
- Decided: Oct 14, 2005 after 179 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: 9 generations back to K960026 (1996). 20 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041938: Maximus OS (Overdenture System), BioHorizons Implant Systems, Inc. (2004) Summary page 1.
- K031345: Nobel Direct, Models 30937, 30938, Nobel Biocare Uas, Inc. (2003) Summary page 1.
- K030639: Xive 3.0 Dental Implant System, Friandent GmbH (2003) Summary page 1.

## Most influential descendants
- K131701: Z5MLB, Z5MLC (2013), 1 descendant of its own
- K130140: Intra-Lock OP Dental Implant (2013), 1 descendant of its own
- K121707: Lew Mdi O-Ball Collared Implant, (2012), 1 descendant of its own
- K200386: Z5-BL (2020), 0 descendants of its own
- K151970: KJ Mini Implant System (2016), 0 descendants of its own

## Indications for use
1. MILO TM Implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. Multiple implants may be restored after a period of time or placed in immediate function. 2. MILO T"' Implants are indicated for the rehabilitation of single and/or multiple maxillary lateral incisors. They are also indicated for the rehabilitation of single and/or multiple mandibular central and lateral incisors. The implants may be restored after a period of time or placed in immediate function.

Source page: https://510kreport.com/device/K050970
Methodology: https://510kreport.com/methodology