# K063106: Revois Implant System

- Pathway: 510(k) (Abbreviated)
- Applicant: Curasan AG
- Decided: Jun 11, 2007 after 243 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K925765 (1993). 72 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013867: Xive Dental Implant System, Friadent GmbH (2002) Summary page 2.
- K021318: Xive Dental Implant System, Friadent GmbH (2002) Summary page 2.
- K024004: Xive Transgingival Dental Implant System, Friadent GmbH (2003) Summary page 2.
- K032284: Xive TG Dental Implant System, Friadent GmbH (2003) Summary page 2.
- K013227: Screw Vent Implant; Tapered Screw Vent Implant, Sulzer Dental, Inc. (2001) Summary page 2.
- K011245: Advent Implant System, Swiss Plus Implant System, Sulzer Dental, Inc. (2001)
- K061629: Certain Prevail Dental Implant, Implant Innovations, Inc. (2007). Cleared while this submission was under review Summary page 2.

## Most influential descendants
- K113539: Revois Pro Implant Stsyem (2013), 0 descendants of its own
- K113042: Revois Implant System (2013), 0 descendants of its own

## Indications for use
The REVOIS® Implant System is an implant system recommended for: Surgical placement in the edentulous or partially edentulous jaw bone (upper or lower jaw bone) to create support for prosthetic devices such as single artificial teeth, fixed or removable bridges or dentures. The titanium implant can be applied either in a one-stage surgical procedure with immediate loading when good primary stability is achieved and with appropriate occlusal loading, or in a two-stage surgical procedure (after osseointegration of the implant). Angled abutments on small diameter implants (3.8 mm) of the REVOIS® Implant System are intended for the anterior region of the mouth and not intended for the posterior region of the mouth due to limited strength of the implant.

Source page: https://510kreport.com/device/K063106
Methodology: https://510kreport.com/methodology