# K962845: Replace HA Coated Implants

- Pathway: 510(k) (Traditional)
- Applicant: Steri-Oss, Inc.
- Decided: Oct 18, 1996 after 88 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
No predicates in its family tree.
644 later devices descend from it; 4 cite it directly.
0 of 645 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) Nobelpharma's 3.75 mm implant: named in the summary without a submission number

## Most influential descendants
- K020646: Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132, & 60162 (2002), 630 descendants of its own
- K022424: Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132 & 60162 (2002), 625 descendants of its own
- K041661: Nobel Biocare Endosseous Implants (2004), 622 descendants of its own
- K050705: Tiunite Implants (2005), 532 descendants of its own
- K050258: Groovy Implants (2005), 511 descendants of its own

## 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/K962845
Methodology: https://510kreport.com/methodology