# K030257: Nobel Perfect Implant System

- Pathway: 510(k) (Special)
- Applicant: Nobel Biocare Uas, Inc.
- Decided: Feb 10, 2003 after 17 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 K962845 (1996). 2 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021584: Replace Scalloped Margin Implant System, Nobel Biocare Uas, Inc. (2002) Summary page 1.

## Most influential descendants
- K033724: Nobel Biocare Centric Post, Models 31234, 31235 and 31236 (2004), 3 descendants of its own
- K040573: Nobel Biocare Permanent Centric Post, Models 31234, 31235, 31236 (2004), 2 descendants of its own
- K050444: Nobelreplace Adapter, Model 32412 (2005), 1 descendant of its own
- K063592: Adapter PS RP-NP, 34551, Adapter PS WP-RP,34552, Abutment Screw PS RP-NP, 34553, Abutment Screw PS WP-RP, 34554 (2007), 0 descendants of its own

## Indications for use
The indications for use for the Nobel Perfect Implant System are the same as the unmodified device, Replace Scalloped Margin Implant System. It is a system with a scalloped coronal implant designed for single stage or two stage surgical procedures. The Nobel Perfect Implant System is intended for use to restore chewing function in edentulous and/or partially edentulous patients.

Source page: https://510kreport.com/device/K030257
Methodology: https://510kreport.com/methodology