# K133991: ISY

- Pathway: 510(k) (Traditional)
- Applicant: Altatec GmbH
- Decided: Aug 6, 2014 after 223 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: 12 generations back to K894595 (1990). 194 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 197 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113779: Conelog Implant System, Altatec GmbH (2012) Summary page 5.
- K083496: Camlog Implant System Modified Implants and Abutments, Altatec GmbH (2009) Summary page 5.
- K120414: Osseospeed Plus, Astra Tech AB (2012) Summary page 5.
- K111421: Sirona Dental Cad/Cam System, Sirona Dental Systems GmbH (2012) Summary page 5.

## Most influential descendants
- K151599: iSy Implant System (2015), 0 descendants of its own
- K143337: CONELOG Titanium base CAD/CAM (2015), 0 descendants of its own

## Indications for use
iSy® Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. iSy® Implant System Abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

Source page: https://510kreport.com/device/K133991
Methodology: https://510kreport.com/methodology