# K021584: Replace Scalloped Margin Implant System

- Pathway: 510(k) (Special)
- Applicant: Nobel Biocare Uas, Inc.
- Decided: Jun 5, 2002 after 22 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: 1 generation back to K962845 (1996). 1 ancestor in all.
12 later devices descend from it; 6 cite it directly.
0 of 14 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.

## Most influential descendants
- K052471: HDC Spider Screw (2005), 4 descendants of its own
- K030257: Nobel Perfect Implant System (2003), 4 descendants of its own
- K033724: Nobel Biocare Centric Post, Models 31234, 31235 and 31236 (2004), 3 descendants of its own
- K071851: HDC Sterile Spider Screw (2007), 2 descendants of its own
- K040573: Nobel Biocare Permanent Centric Post, Models 31234, 31235, 31236 (2004), 2 descendants of its own

## Indications for use
The Replacem Scalloped Margin Implant System is an implant with a scalloped coronal margin, designed for single stage or two stage surgical procedures. The Replacem Scalloped Margin Implant System is intended for use to restore chewing fkction in edentulous and/or partially edentulous patients.

Source page: https://510kreport.com/device/K021584
Methodology: https://510kreport.com/methodology