# K020646: Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132, & 60162

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare Uas, Inc.
- Decided: May 29, 2002 after 90 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 K911592 (1993). 3 ancestors in all.
630 later devices descend from it; 4 cite it directly.
0 of 634 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962845: Replace HA Coated Implants, Steri-Oss, Inc. (1996) Summary page 1.
- K973423: Steri-Oss 3.25 MM Replace (Hydroxyapatite-Coated)Dental Implant, Steri-Oss, Inc. (1997) Summary page 1.

## Most influential descendants
- 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
- K061003: SFB & CFB Implants (2006), 507 descendants of its own

## Indications for use
The Replace” HA Coated Implant is for single-stage or two-stage surgical procedures and cement or screw retained restorations. The Replace HA Coated Implant is intended for immediate placement and function on single tooth and/or multiple tooth applications in good quality bone (type I or type Il bone), to restore chewing function.

Source page: https://510kreport.com/device/K020646
Methodology: https://510kreport.com/methodology