# K090174: Tsi; Eri

- Pathway: 510(k) (Traditional)
- Applicant: Oco Biomedical
- Decided: Sep 14, 2009 after 234 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: 7 generations back to K944964 (1995). 64 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033392: Immediate Stabilizing Implant (Isi), O Co., Inc. (2003) Summary page 1.
- K023336: Oco Dental Implant (5.0MM Diameter), O Co., Inc. (2002) Summary page 1.
- K052369: Exfeel Implant System, Megagen Co., Ltd. (2006) Summary page 1.

## Most influential descendants
- K110337: Universal Maxillary Molar (2012), 1 descendant of its own
- K171197: Zuga Dental Implant System (2018), 0 descendants of its own
- K142846: BBX1, BBX2, BBX1MO, BBX1MC (2016), 0 descendants of its own
- K122198: 6.00MM X 6.00MM Macro External Implant System (2013), 0 descendants of its own

## Indications for use
The TSI and ERI Dental Implants are artificial root structures intended for permanent surgical implantation in the bone for the purpose of single or multiple tooth replacements (splinted or free standing), or for stabilization of a prosthetic system, such as artificial teeth in order to restore the patient's chewing function. The TSI and ERI can be placed in the anterior or posterior mandible/maxilla for immediate or delayed loading purposes. Immediate loading is only intended when good primary stability is achieved and appropriate occlusal loading.

Source page: https://510kreport.com/device/K090174
Methodology: https://510kreport.com/methodology