# K122198: 6.00MM X 6.00MM Macro External Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Oco Biomedical
- Decided: Apr 5, 2013 after 255 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 K894595 (1990). 121 ancestors in all.
No later device cites it as a predicate yet.
0 of 122 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110337: Universal Maxillary Molar, Oco Biomedical (2012)
- K090174: Tsi; Eri, Oco Biomedical (2009) Summary page 2.
- K033392: Immediate Stabilizing Implant (Isi), O Co., Inc. (2003) Summary page 2.
- K023336: Oco Dental Implant (5.0MM Diameter), O Co., Inc. (2002) Summary page 2.
- K061319: Spectra System, Implant Direct, LLC (2006) Summary page 2.
- K071161: Endosseous Dental Implant System, Southern Implants, Inc. (2007) Summary page 2.
- K081302: Rescue External Implant System, Megagen Implant Co., Ltd. (2008) Summary page 2.
- K101732: Astra Tech Implant System, Astra Tech AB (2011) Summary page 2.
- K010185: 6.0 X 5.7MM Dental Implant, Bicon, Inc. (2002) Summary page 2.
- K092035: Bicon Implants with a 2.5MM Internal Connection, Bicon, LLC (2009) Summary page 2.
- K073368: 5.0 X 5.0MM Dental Implant and 6.0 X 5.0 Dental Implant, Bicon, LLC (2008) Summary page 2.
- K062044: The 5.0 X 6.0MM Dental Implant, Bicon, Inc. (2006) Summary page 2.
- K050712: 4.5.* 6.0MM Dental Implant and 6.0*6.0 MM Dental Implant, Bicon, Inc. (2005) Summary page 2.
- K042637: The 5.0 X 6.0MM Dental Implant, Bicon, Inc. (2004) Summary page 2.

## Indications for use
The I Macro 6.0mmr X 6.0mm Implant system is intended for implantation in the maxillary or mandibular molar region where bone exists. This Macro implant provides support for fixed or removable dental prostheses in a single tooth, partially edentulaus 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/K122198
Methodology: https://510kreport.com/methodology