# K110337: Universal Maxillary Molar

- Pathway: 510(k) (Traditional)
- Applicant: Oco Biomedical
- Decided: Mar 16, 2012 after 406 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: 8 generations back to K894595 (1990). 102 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 104 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.
- K090174: Tsi; Eri, Oco Biomedical (2009) Summary page 1.
- K081302: Rescue External Implant System, Megagen Implant Co., Ltd. (2008) Summary page 1.
- K061319: Spectra System, Implant Direct, LLC (2006) Summary page 1.
- K071161: Endosseous Dental Implant System, Southern Implants, Inc. (2007) Summary page 1.

## Most influential descendants
- K122198: 6.00MM X 6.00MM Macro External Implant System (2013), 0 descendants of its own

## Indications for use
The I Macro Implant system is intended for implantation in the mandibular molar region where bone exists and the surgeon has determined that placement of a narrower diameter implant would increase the chance of failure due to poor primary stability, or increased surgical procedures leading to complications. This I Macro implant provides support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or complete arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with proper occlusal loading, to restore the chewing function.

Source page: https://510kreport.com/device/K110337
Methodology: https://510kreport.com/methodology