# K022113: 3I Dental Implant Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations, Inc.
- Decided: Sep 19, 2002 after 83 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: 2 generations back to K891615 (1989). 11 ancestors in all.
463 later devices descend from it; 6 cite it directly.
0 of 475 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935544: 3I Standard Threaded/Self-Tapping Threaded Implants Modification, Implant Innovations International, Inc. (1995) Summary page 1.
- K952811: 3I Oral/Maxillofacial Bone Fixation System: Stainless Steel Bone-Mesh/Plate & Screws, Implant Innovations, Inc. (1995) Summary page 1.
- K962014: 3I Single Use, Disposable Drills,Taps,Burs, Etc., Implant Innovations, Inc. (1996) Summary page 1.
- K962465: TIL313 Abutment and Retaining Screw Systems, Implant Innovations, Inc. (1996) Summary page 1.
- K965077: Single Toot Abutment System (Sta or ST Abutment ) for Single Ooth Cement Retained Restorations, Implant Innovations, Inc. (1997) Summary page 1.
- K992334: Endosseous Implants and Abutments- Tin Coating, Implant Innovations, Inc. (1999) Summary page 1.
- K012911: 3I Locater Abutment System, Implant Innovations, Inc. (2001)
- K013570: Osseotite Dental Implants, Implant Innovations, Inc. (2001)

## Most influential descendants
- K030614: 3I Dental Implants (2003), 319 descendants of its own
- K041402: Modification to Osseotite NT Certain Implants (2004), 318 descendants of its own
- K051189: Prevail Dental Implants (2005), 317 descendants of its own
- K051461: 3I Osseotite Dental Implants (2005), 312 descendants of its own
- K040807: Mis Dental Implant System (2004), 218 descendants of its own

## Indications for use
3i Dental Accessories are indicated for use in surgical and restorative applications when placing dental implants.

Source page: https://510kreport.com/device/K022113
Methodology: https://510kreport.com/methodology