# K021915: Transitional Implants

- Pathway: 510(k) (Abbreviated)
- Applicant: Intra-Lock International
- Decided: Dec 19, 2002 after 191 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 K781060 (1978). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972351: Sendax Mdi (Mini Dental Implant), Sendax Mdic Management, Inc. (1997) Summary page 1.
- K980620: Dentatus Mti  Modular Transitional Implants and Prosthetic System, Dentatus USA, Ltd. (1998) Summary page 1.
- K990983: Modification to Imtec Sendax Mdi, Imtec Corp. (1999) Summary page 1.

## Indications for use
This device is designed to provide immediate transitional splinting stability or fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients. It is indicated for a maximum of one year.

Source page: https://510kreport.com/device/K021915
Methodology: https://510kreport.com/methodology