# K964220: Replace Titanium Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Steri-Oss, Inc.
- Decided: Mar 5, 1997 after 134 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
24 later devices descend from it; 4 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Steri-Oss Titanium Implants: named in the summary without a submission number
- (no number) Steri-Oss Healing Screws: named in the summary without a submission number
- (no number) Steri-Oss Healing Abutments: named in the summary without a submission number
- (no number) Steri-Oss Abutments: named in the summary without a submission number

## Most influential descendants
- K070905: Endosseous Dental Implant System (2007), 17 descendants of its own
- K163634: External Hex Implants (2017), 13 descendants of its own
- K163060: Deep Conical (DC) Implants and Accessories (2017), 7 descendants of its own
- K193084: TIB Abutment System (2020), 3 descendants of its own
- K034014: Spi Contact Dental Implant (2004), 3 descendants of its own

## Recalls of this device
- Jan 27, 2003 · Not classified · Z-0575-03: Misprinted radiographic template plates. Misprinted labeling.

## Indications for use
The implant is indicated for use in restoring masticatory function in the edentulous and/or partially edentulous patient.

Source page: https://510kreport.com/device/K964220
Methodology: https://510kreport.com/methodology