# K050393: The Guided Surgery Concept

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: May 4, 2005 after 77 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 K000018 (2000). 3 ancestors in all.
258 later devices descend from it; 4 cite it directly.
0 of 262 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030685: Teeth in an Hour - Ark Implant Concept, Nobel Biocare AB (2004) Summary page 1.

## Most influential descendants
- K053602: Procera Software, Model 33145 (2006), 248 descendants of its own
- K062493: Lava Software (2006), 242 descendants of its own
- K100152: Sirona Cad/Cam System (2010), 240 descendants of its own
- K093113: Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam Abutment (2009), 169 descendants of its own
- K101465: Straumann Cares Bridge; Straumann Cares Dolder Bar (2010), 167 descendants of its own

## Indications for use
The Guided Surgery Concept and Teeth-in-an-Hour are indicated for the treatment of single, partially and totally edentulous jaws for placement of implant fixtures with immediate function to restore patient esthetics and chewing function. The following prerequisites must be fulfilled: - adequate amount of jaw bone - the quality of jaw bone must be judged as adequate

Source page: https://510kreport.com/device/K050393
Methodology: https://510kreport.com/methodology