# K950204: 3I Standard Threaded/Self-Tapping Threaded Implants, Miniplants (TM)

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations, Inc.
- Decided: Sep 27, 1995 after 252 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
322 later devices descend from it; 3 cite it directly.
0 of 323 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
- 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
- K063286: Osseotite; Osseotite NT; XP; TG Osseotite (2007), 211 descendants of its own

## Recalls of this device
- Aug 3, 2007 · Not classified · Z-1221-2007: The LTX XP Miniplant, BIOMET 3i dental implant, was labeled incorrectly. The 13MM implants were labeled and packaged as 11.5MM implants and 11.5MM implants were labeled and packaged as 13MM implants.
- Jan 28, 2003 · Not classified · Z-0665-03: Sterile Endosseous implants may be packaged in mislabeled packaging with the incorrect size.

Source page: https://510kreport.com/device/K950204
Methodology: https://510kreport.com/methodology