# K040757: Sic Pro

- Pathway: 510(k) (Traditional)
- Applicant: Sic Invent AG
- Decided: Apr 13, 2005 after 384 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: 7 generations back to K894595 (1990). 47 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033984: Straumann Dental Implant System, Institut Straumann AG (2004). Cleared while this submission was under review Summary page 2.
- K040946: Ankylos Dental Implant System, Friadent GmbH (2004). Cleared while this submission was under review Summary page 2.
- K041661: Nobel Biocare Endosseous Implants, Nobel Biocare Uas, Inc. (2004). Cleared while this submission was under review Summary page 2.
- K022859: Abutment and Prosthetic Accessories to the Iti Dental Implant System, Straumann USA (2002) Summary page 2.
- K032302: Xive TG Abutments, Friadent GmbH (2003) Summary page 2.

## Most influential descendants
- K061500: Sicace Dental Implant System and Sic Angled Abutments (2006), 1 descendant of its own
- K073622: Easy Grip Dental Implant System (2008), 0 descendants of its own

## Indications for use
The SIC pro System Dental Implant is a root form endosseous dental implant system that is indicated to be implanted in the upper and/or lower jaw arches. The implants may be used in combination with various SIC pro System Abutments for single or multiple unit prosthetic attachment to restore a patient's chewing function. Patient's must be applicable for dental treatment with endosseous implants. In cases where the ridge is too narrow to recieve a 4.2mm or 5.3mm diameter implant, the 3.3mm implant can be used. Under such conditions, we highly recommend the placement of additional fixtures to share the occlusal load of the prosthetic restoration. The SIC pro System Abutment is intended to be placed into the SIC pro System Implant to provide a safe and effective fit of screw retained and/or cementable crowns and bridges.

Source page: https://510kreport.com/device/K040757
Methodology: https://510kreport.com/methodology