# K042971: Titan Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Titan Implants, Inc.
- Decided: Jan 14, 2005 after 78 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: 6 generations back to K925765 (1993). 45 ancestors in all.
No later device cites it as a predicate yet.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031632: Osseotite Iol Implants and Osseotite Certain Iol Implants, Implant Innovations, Inc. (2003) Summary page 3.
- K033430: 3I TG Osseotite Implant, Models TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611, TG5613, TG5615, Implant Innovations, Inc. (2003) Summary page 3.
- K972029: Bicon Dental Implants II Part Abutment System, Bicon, Inc. (1997) Summary page 3.
- K994037: The 4.5MM Diameter Bicon Dental Implant, Bicon, Inc. (2000) Summary page 3.
- K010185: 6.0 X 5.7MM Dental Implant, Bicon, Inc. (2002) Summary page 3.
- K972313: The Maestro System, BioHorizons Implant Systems, Inc. (1997) Summary page 3.
- K010458: The Maestro System, BioHorizons Implant Systems, Inc. (2001) Summary page 3.
- K994376: Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2 3.4MM Steeped Cylinder Implant with Frios HA, Friadent GmbH (2000) Summary page 3.
- K021318: Xive Dental Implant System, Friadent GmbH (2002) Summary page 3.
- K032140: 5.0 X 5MM Endopore Endosseous Dental Implant System, Innova Life Sciences Corp. (2003) Summary page 3.
- K040714: Hybrid Endopore Endosseous Dental Implant, Innova Corp. (2004) Summary page 3.
- K002037: Lifecore Biomedical Dental Implant Systems, Lifecore Biomedical, Inc. (2001) Summary page 3.
- K964220: Replace Titanium Implant System, Steri-Oss, Inc. (1997) Summary page 3.
- K980439: Replace Cylindrical Implants, Steri-Oss, Inc. (1998) Summary page 3.
- K030007: Iti Dental Implant System, Straumann USA (2003) Summary page 3.
- K931767: Astra Tech Implants-Dental System, Astra Tech, Inc. (1994) Summary page 3.

## Indications for use
The TITAN Dental Implant System is intended to be surgically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch and to provide support for crowns, bridges or overdentures.

Source page: https://510kreport.com/device/K042971
Methodology: https://510kreport.com/methodology