# K063523: Zimmer One Piece Implant, 3.7MM and 4.7MM, Models ZOP37S10, 11, 13, 16; ZOP37A10, 11, 13, 16; ZOP47S10, 11, 13, 16; ZOP4

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Dental, Inc.
- Decided: Feb 16, 2007 after 86 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K091182: Champions Implants GMBH Mimi 1-Piece Precision Implant, Model 1000 UP to 6000 (2010), 3 descendants of its own
- K110548: Osi O-Ball Abutment Head Implants (2011), 2 descendants of its own
- K213576: Tatum Surgical Dental Implant System (2022), 1 descendant of its own
- K254145: Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) (2026), 0 descendants of its own

Source page: https://510kreport.com/device/K063523
Methodology: https://510kreport.com/methodology