# K102822: Implant-One System

- Pathway: 510(k) (Traditional)
- Applicant: Custom Dental Implants, Inc.
- Decided: Jan 10, 2011 after 104 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 K925765 (1993). 82 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063341: 3I Osseotite Certain Dental Implants, Implant Innovations, Inc. (2007) Summary page 1.
- K072642: Biomet 3I Dental Abutments and Restorative Components, Biomet 3i, Inc. (2007) Summary page 1.
- K061410: Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant System,AV;Zimmer One-Piece Implant, Zimmer Dental, Inc. (2006) Summary page 1.
- K061847: Zimmer Contour Ceramic Abutment, Models ZRA341S, ZRA342S, KRA451S, ZRA452S, Zimmer Dental, Inc. (2006) Summary page 1.
- K073075: Frialit Plus, Xive S Plus, Xive TG Plus, Ankylos Plus, Dental Implant Systems, Dentsply International, Inc. (2008) Summary page 1.

## Most influential descendants
- K173701: Implant-One System (2018), 1 descendant of its own
- K230242: OsteoCentric Dental Implant System (2023), 0 descendants of its own
- K141159: Konus Dental Implant System (2015), 0 descendants of its own

## Indications for use
The Implant-One system is indicated for surgical placement in partially or completely edentulous upper or lower jaws to provide a means for prosthetic attachment to restore a patient's chewing function. The Implant-One system is indicated for immediate loading only when primary stability is achieved and with the appropriate occlusal loading.

Source page: https://510kreport.com/device/K102822
Methodology: https://510kreport.com/methodology